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Renegade™ HI-FLO™ Kit M001183030Recalls & reported problems

Boston Scientific Corporation · Microcatheter Kit · Class 2

All models of Renegade HI-FLO Kit (5)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Boston Scientific Renegade Hi-Flo microcatheter kit is used to deliver chemotherapy drugs into liver tumors through the hepatic artery. The 28 reports mostly describe the catheter breaking, cracking, or its tip coming apart, often while still in the package or during preparation, plus coating peeling off and packaging that was hard to open. No deaths and no injuries were reported, and in each case the procedure was finished with another catheter. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
28
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 08714729280781), received between Aug 21, 2018 and Jan 26, 2026 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Break” (14 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break14
  • Material Integrity Problem5
  • Detachment of Device or Device Component4
  • Difficult to Open or Remove Packaging Material4
  • Material Deformation3
  • Fracture2
  • Stretched2
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Consequences Or Impact To Patient20
  • No Clinical Signs, Symptoms or Conditions4
  • No Patient Involvement4

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 26, 2026Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE HEPATIC ARTERY. A 135/20 RENEGADE HI FLO CATHETER-INFUSION WAS SELECTED FOR USE IN A TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION TO TREAT LIVER CANCER. DURING PREPARATION, THE TIP OF THE CATHETER WAS COMPLETELY SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24177623 ↗
  • MalfunctionSep 11, 2023Break; Break

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 135/20 KIT RENEGADE HI FLO CATHETER WAS SELECTED FOR USE. DURING UNPACKING, THE CATHETER FRACTURED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17720454 ↗
  • MalfunctionDec 16, 2021Break; Break

    IT WAS REPORTED THAT THE MICROCATHETER WAS FRACTURED. A 135/20 RENEGADE HI-FLO CATHETER-INFUSION WAS SELECTED FOR USE ON THE LIVER FOR CHEMICAL EMBOLIZATION. DURING PREPARATION, AS SOON AS THE PHYSICIAN OPENED THE PACKAGE, THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13022481 ↗
  • MalfunctionMay 17, 2021Break; Break

    IT WAS REPORTED THAT THE CATHETER WAS BROKEN. THE TARGET LESION WAS LOCATED IN THE LIVER. A 135/20 RENEGADE HI-FLO KIT WAS SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT THE MIDDLE PART OF THE CATHETER WAS BROKEN. THE DEVICE NEVER ENTERED THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11832968 ↗
  • MalfunctionDec 8, 2020Fracture; Fracture

    IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. THE TARGET LESION AREA WAS LOCATED IN THE LIVER. A 135/20 RENEGADE HI FLO KIT CATHETER INFUSION WAS SELECTED FOR USE IN A CHEMOEMBOLIZATION PROCEDURE. DURING PREPARATION, IT WAS NOTED THAT THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT IS STABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10968738 ↗
  • MalfunctionNov 5, 2020Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT THE COATING PEELED OFF. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS HEPATIC ARTERY. THREE 135/20 RENEGADE HI-FLO KIT WERE SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE COATING OF THE GUIDEWIRE PEELED OFF. ANOTHER TWO MICROCATHETER OF THE SAME BATCH WERE UNPACKED BUT THE SAME PROBLEM OCCURRED. THE DEVICE WAS SIMPLY PULLED OUT AND THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10791361 ↗
  • MalfunctionNov 5, 2020Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT THE COATING PEELED OFF. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS HEPATIC ARTERY. THREE 135/20 RENEGADE HI-FLO KIT WERE SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE COATING OF THE GUIDEWIRE PEELED OFF. ANOTHER TWO MICROCATHETER OF THE SAME BATCH WERE UNPACKED BUT THE SAME PROBLEM OCCURRED. THE DEVICE WAS SIMPLY PULLED OUT AND THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10791359 ↗
  • MalfunctionNov 5, 2020Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT THE COATING PEELED OFF. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS HEPATIC ARTERY. THREE 135/20 RENEGADE HI-FLO KIT WERE SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE COATING OF THE GUIDEWIRE PEELED OFF. ANOTHER TWO MICROCATHETER OF THE SAME BATCH WERE UNPACKED BUT THE SAME PROBLEM OCCURRED. THE DEVICE WAS SIMPLY PULLED OUT AND THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10791346 ↗
  • MalfunctionOct 15, 2020Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT THE COATING PEELED OFF. THE TARGET LESION WAS LOCATED IN AN ARTERY IN THE LIVER. A 135/20 RENEGADE HI-FLO KIT WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS FOUND OUT THAT THE COATING OF THE DEVICE PEELED OFF. THERE WERE NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10683663 ↗
  • MalfunctionOct 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE TIP OF THE MICROCATHETER HAD DETACHED. A 135/10 RENEGADE HI-FLO KIT WAS SELECTED FOR USE ON THE LIVER. DURING THE PROCEDURE, THE PHYSICIAN OPENED THE MICROCATHETER AND FOUND THE TIP OF THE MICROCATHETER HAD DETACHED AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10670859 ↗
  • MalfunctionSep 29, 2020Break; Stretched; Break; Stretched

    IT WAS REPORTED THAT THE CATHETER WAS BROKEN. A 135/20 RENEGADE HI-FLO KIT WAS SELECTED FOR USE. PRIOR PREPARING THE DEVICE, IT WAS NOTED THAT THE CATHETER WAS BROKEN AND LOOKS LIKE IT WAS STRETCHED WHEN TRIED TO REMOVE FROM THE PROTECTIVE LOOP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Patient problems: No Patient Involvement

    MAUDE report 10600739 ↗
  • MalfunctionAug 12, 2020Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT THE COATING PEELED OFF. THE TARGET LESION AREA WAS LOCATED IN THE LEFT GASTRIC ARTERY. A 135/20 RENEGADE HI FLO KIT WAS SELECTED FOR USE. DURING THE PROCEDURE, THE MICROCATHETER WAS ADVANCED INTO THE PATIENT'S BODY, IT WAS NOTED THAT THE COATING OF THE SUPPORTING GUIDEWIRE PEELED OFF AND COULD NOT BE USED. NO PEELED COMPONENTS WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10396510 ↗
  • MalfunctionJul 6, 2020Break; Break

    IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. A RENEGADE HI-FLO KIT WAS SELECTED FOR USE. DURING UNPACKING OF DEVICE, THE PHYSICIAN FOUND IT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10233441 ↗
  • MalfunctionMar 30, 2020Fracture; Fracture

    IT WAS REPORTED THAT THE MICROCATHETER WAS FRACTURED. A 135/20 RENEGADE HI-FLO KIT WAS SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT THE MICROCATHETER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

    Patient problems: No Patient Involvement

    MAUDE report 9899286 ↗
  • MalfunctionMar 4, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT PROXIMAL PART OF THE DEVICE WAS SEPARATED FROM ITS SHAFT. A 135/20 RENEGADE HI-FLO KIT WAS SELECTED FOR USE IN THE PROSTATE. DURING PREPARATION FOR THE PROCEDURE, AFTER THE DEVICE WAS FLUSHED AND PULLED OUT SMOOTHLY AND SLOWLY FROM INSIDE THE SHEATH, THE PROXIMAL PART WAS NOTED TO BE SEPARATED FROM IT'S SHAFT. THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9788020 ↗
  • MalfunctionAug 16, 2019Break; Stretched; Break; Stretched

    IT WAS REPORTED THAT THE CATHETER DETACH OCCURRED. A 135/20 RENEGADE HI-FLO CATHETER WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE CATHETER WAS BENT IN A RING AND BECAME UNRAVELED AND CAME APART AS IT WAS REMOVED FROM THE CARRIER HOOP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8902728 ↗
  • MalfunctionAug 6, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE CATHETER SEPARATED AND BROKE. A 135/20 RENEGADE HI-FLO KIT WAS SELECTED FOR USE. DURING PREOPERATION, IT WAS NOTED THAT THE CATHETER SEPARATED AND BROKE WHEN REMOVED OUT OF THE PROTECTIVE HOOP. THE DEVICE DID NOT GO INTO THE PATIENT. NO PATIENT COMPLICATIONS REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8864602 ↗
  • MalfunctionJul 17, 2019Break; Break

    IT WAS REPORTED THAT THE DEVICE BROKE. A 130/20 RENEGADE HI-FLO KIT WAS SELECTED FOR USE. DURING PREPARATION, FLUSHING WAS DONE IN THE HOOP AND THE CATHETER. HOWEVER, WHEN THE CATHETER AND THE WIRE WAS REMOVED FROM THE HOOP, THE CATHETER WAS FRACTURED AND EXPOSED SOME OF THE BRAIDING OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Patient Involvement

    MAUDE report 8799024 ↗
  • MalfunctionJul 17, 2019Break; Difficult to Remove; Difficult to Open or Remove Packaging Material; Break; Difficult to Remove; Difficult to Open or Remove Packaging Material

    IT WAS REPORTED THAT THE OUTER SHAFT OF THE RENEGADE BROKE. A 135/20 RENEGADE HI-FLO KIT WAS SELECTED FOR USE. DURING PREPARATION, THE PACKAGING OF THE RENEGADE THAT WAS PRE-LOADED WITH A TRANSEND GUIDEWIRE WAS FLUSHED BUT RESISTANCE WAS FELT WHEN TRIED TO TAKE OUT THE CATHETER. SUBSEQUENTLY, THE OUTER SHAFT OF THE RENEGADE CATHETER BROKE WHEN GENTLY PULLED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8798207 ↗
  • MalfunctionFeb 25, 2019Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02-FEB-2019. IT WAS REPORTED THAT THE MICRO CATHETER COULD NOT BE REMOVED FROM THE SHEATH. THE TARGET LESION WAS LOCATED AT THE LUNGS. A 135/20 RENEGADE HI-FLO KIT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE MICRO CATHETER COULD NOT BE TAKEN OUT FROM THE SHEATH WHEN UNPACKING. THE CARRIER HOOP WAS RE-FLUSHED WITH SALINE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WAS 1 FRACTURE ON THE SHAFT LOCATED AT 26.5CM FROM THE HUB.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8366329 ↗
  • MalfunctionFeb 12, 2019Break; Break

    IT WAS REPORTED THAT THE CATHETER WAS FOUND FRACTURED AFTER FLUSHING. A 135/20 RENEGADE HI-FLO KIT WAS SELECTED FOR USE. WHEN UNPACKING, IT WAS NOTED THAT THE CATHETER WAS FOUND FRACTURED AFTER FLUSHING. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT WAS STABLE POST PROCEDURE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8331421 ↗
  • MalfunctionDec 6, 2018Break; Material Deformation; Break; Material Deformation

    IT WAS REPORTED THAT A CATHETER FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER ARTERY. A 135/10 RENEGADE HI-FLO KIT WAS SELECTED FOR USE. THE DEVICE WAS UNPACKED AND THE GUIDEWIRE AND PROTECTOR WERE REMOVED. THEN THE DEVICE WAS FLUSHED THROUGH THE FLUSHING PASSAGES ON BOTH SIDES OF THE PROTECTOR AND THE MICROCATHETER WAS REMOVED. HOWEVER, THE DEVICE WAS FOUND DEFORMED AND FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8138520 ↗
  • MalfunctionNov 15, 2018Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06NOV2018. IT WAS REPORTED THAT THE MICRO CATHETER COULDN'T BE TAKEN OUT FROM THE PROTECTOR AFTER FLUSHING A 135/20 RENEGADE HI-FLO KIT WAS SELECTED FOR USE DURING A TACE PROCEDURE FOR A PATIENT WITH LIVER CANCER. DURING PREPARATION, IT WAS REPORTED THAT THE MICRO CATHETER COULDN'T BE TAKEN OUT FROM THE PROTECTOR AFTER FLUSHING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION AFTER THE PROCEDURE WAS STABLE. HOWEVER, ANALYSIS REVEALED THAT THE SHAFT WAS FRACTURED 50.2CM FROM THE HUB. DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR EVALUATION. RETURNED PRODUCT CONSISTED OF A RENEGADE HI-FLO MICRO-CATHETER. THE HUB, SHAFT AND TIP WERE MICROSCOPICALLY EXAMINED. THIS DEVICE SHOWED DAMAGE CONSISTING OF 1 FRACTURE ON THE SHAFT. THE FRACTURE WAS LOCATED 50.2CM FROM THE HUB. THE SHAFT WAS NOT COMPLETELY SEPARATED THE INNER LINER WAS STILL CONNECTED. THE STRETCHING AND THE FRACTURE THAT WAS NOTICED ON THE DEVICE ARE CONSISTENT WITH THE DEVICE BEING REMOVED FROM THE SHIPPING TUBE WITHOUT BEING COMPLETELY HYDRATED WITH SALINE. THE DISTAL END OF THE SHAFT SHO

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8075437 ↗
  • MalfunctionOct 5, 2018Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2018. IT WAS REPORTED THAT THE TIP OF THE MICROCATHETER WAS LIFTED UP. A 135/20 RENEGADE HI-FLO KIT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE TIP OF THE MICROCATHETER WAS LIFTED UP AND THE DEVICE COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT CONDITION WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED SHAFT FRACTURE AND PERFORATION. DEVICE EVAL BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF A RENEGADE HI-FLO MICRO-CATHETER WITH A GUIDEWIRE STUCK IN THE DEVICE. THE HUB, SHAFT AND TIP WERE MICROSCOPICALLY EXAMINED. THE SHAFT SHOWED MULTIPLE KINKS THROUGHOUT ITS LENGTH. THE SHAFT WAS FRACTURED IN 2 PLACES. THE 1ST FRACTURE WAS LOCATED 11.5CM FROM THE HUB AND THE 2ND FRACTURE WAS LOCATED 25CM FROM THE HUB. THE DEVICE SHOWED THAT THE GUIDE WIRE HAD PERFORATED THE SHAFT. THE LOCATION OF THE PERFORATION WAS 18CMCM FROM THE TIP. THE DEVICE WAS STRETCHED FROM THE TIP TO 18CM PROXIMALLY. THE WIRE COULD NOT BE REMOVED DUE TO THE DAMAGE OF THE SHAFT CONSTRICTING DOWN ON THE GUIDEWIRE. INSPECTION OF THE REMAINDER OF TH

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7938910 ↗
  • MalfunctionSep 24, 2018Break; Material Deformation; Break; Material Deformation

    IT WAS REPORTED THAT A CATHETER BREAK OCCURRED. A 135/20 RENEGADE HI-FLO KIT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS BROKEN AND TWISTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS POST-PROCEDURE WAS STABLE. DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANALYSIS. RETURNED PRODUCT CONSISTED OF A RENEGADE HI-FLO MICRO-CATHETER. THE HUB, SHAFT AND TIP WERE MICROSCOPICALLY EXAMINED. THE DEVICE SHOWED BUCKLING FROM THE HUB TO 9CM DISTALLY. THE DEVICE SHOWED MULTIPLE KINKS THROUGHOUT THE CATHETER SHAFT. THE EXTREME DAMAGE THAT WAS NOTICED ON THIS DEVICE IS CONSISTENT WITH HANDLING AND MAY HAVE HAD INTERFERENCE WITH ANOTHER DEVICE. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7901636 ↗

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