Chameleon 8x40Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07290016745047), received between Jun 5, 2020 and Aug 26, 2024 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 17, 2021Open, Classified

   The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the protector sleeve). If the balloon is damaged while removing the protector sleeve and the catheter is subsequently used in a patient procedure, patient harm may potentially occur, including perforation of vessels, foreign body in patient, embolism, risks associated with surgical intervention, or delay to treatment/therapy.

   Z-0557-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2024Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  ACCORDING TO THE REPORTER, THE PRODUCT WAS OPENED AND INTRODUCED TO THE PROCEDURE TABLE. THE RADIOLOGY TECHNICIAN PULLED THE STAINLESS STEEL PIN AND THEN PROCEEDED TO PULL THE WHITE PLASTIC COVER FROM THE BALLOON. ON THE FIRST ATTEMPT TO SLIDE OFF THE WHITE PLASTIC COVER, IT DID NOT SLIDE OFF SO THEY HAD TO USE MORE FORCE TO REMOVE IT. THEY EVEN USED A 4X4 GAUZE SPONGE TO HELP INCREASE THE GRASP ON THE BALLOON SHAFT AND THEN THEY HAD TO PULL HARDER THAN NORMAL TO REMOVE THE WHITE PLASTIC SLEEVE BALLOON COVER. THE RADIOLOGY TECHNICIAN WAS STRUGGLING WITH IT AND WAS ASKED TO INSPECT THE BALLOON TO MAKE SURE THE BALLOON WAS NOT DAMAGED. THE RADIOLOGY TECHNICIAN SAID IT WAS NOT (BALLOON WAS NOT DAMAGED AND THE SHAFT OF THE BALLOON CATHETER WAS NOT STRETCHED) AND THEY USED THE BALLOON SUCCESSFULLY ON THE PROCEDURE. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO DAMAGE TO THE DEVICE'S BOX AND TO THE DEVICE'S ACTUAL PACKAGING. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PER INSTRUCTIONS FOR USE (IFU) AND HAD NO PROBLEM. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072161 ↗
• MalfunctionAug 20, 2024Leak/Splash; Product Quality Problem; Difficult to Open or Remove Packaging Material; Leak/Splash; Product Quality Problem; Difficult to Open or Remove Packaging Material

  ACCORDING TO THE REPORTER, DURING BALLOON INFLATION INSIDE THE PATIENT¿S VEIN, THE PHYSICIAN FELT ADEQUATE PRESSURE WAS APPLIED TO OPEN THE VESSEL, AND IT WAS NOT UNTIL THEY DEFLATED THE BALLOON THAT THEY NOTICED BLOOD INFILTRATION. UPON FURTHER INVESTIGATION, IT WAS FOUND THAT THE PROXIMAL END OF THE BALLOON LEAKED WHERE IT WAS ATTACHED TO THE SHAFT CLOSEST TO THE EXIT PORT CAUSING PRESSURE IN THE BALLOON TO NOT BE SUSTAINED AND HAD LEAKAGE OF CONTRAST. IT WAS STATED THAT THERE WAS NO BURST OCCURRED, JUST A SUBTLE LEAK DETECTED BY INFILTRATION OF BLOOD WHILE IN VESSEL. NO DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED (CRACK, CUT, ETC.). THERE WERE 3-4 INFLATIONS (IN TOTAL) APPLIED TO THE DEVICE PRIOR TO THE ISSUE OCCURRING. ALSO, PRIOR TO USE, IT WAS OBSERVED THAT THE HOOKED PIN IN THE DISTAL TIP OF THE BALLOON CATHETER WAS VERY DIFFICULT TO REMOVE BUT IT WAS REMOVED AS NORMAL BY PULLING IT OUT USING THEIR FINGERS, BUT IT REQUIRED MORE FORCE THAN NORMAL. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. CHG (CHLORHEXIDINE GLUCONATE) WASH THE CLEANING AGENT USED ON THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. A SHEATH WAS IN PLACE AS NORMAL BUT THE LEAK D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20003324 ↗
• MalfunctionMay 26, 2023Detachment of Device or Device Component; Infusion or Flow Problem; Detachment of Device or Device Component; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, DURING TREATMENT, THE DEVICE'S THIRD PORT WOULD NOT WORK. THERE WAS NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE AND FLUSHING WAS PERFORMED PER THE IFU (INSTRUCTION FOR USE), AND NO ISSUE WAS IDENTIFIED. THERE WAS NO DAMAGE TO THE DEVICE'S EXTERNAL PACKAGING AND BOX. THE DEVICE WAS NOT REPAIRED, THERE WAS NO LEAK, TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. IT WAS ALSO STATED THAT SHEATH AND INFLATION DEVICE WAS BEING UTILIZED WITH THE DEVICE. INTRODUCER SHEATH WAS USED, THE BALLOON WAS INFLATED AND DEFLATED. THE DEVICE'S TIP HAD BROKE OFF FROM THE SHAFT UPON EXIT. THE DEVICE WAS NOT SUCCESSFULLY USED. THE BALLOON AND CATHETER WERE REMOVED TO RESOLVE THE ISSUE. THE TREATMENT WAS PROCEEDED AND COMPLETED. THERE WAS NO MEDICAL INTERVENTION DONE TO THE PATIENT AND THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17014277 ↗
• MalfunctionDec 22, 2021Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Device Fell; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Device Fell

  ACCORDING TO THE REPORTER, THE TECH WAS PREPPING THE BALLOON PRIOR TO USE. IT WAS SAID THAT WHEN THE TECH WAS ATTEMPTING TO PULL OUT THE HOLDING PIN, IT HAD A LOT OF RESISTANCE. THE WHITE PROTECTIVE SLEEVE WAS SAID TO BE STILL ON THE BALLOON. WHEN THE TECH PULLED THE PIN OUT, THE BALLOON WHICH WAS STILL COVERED OF WHITE PROTECTIVE SLEEVE, BROKE APART FROM THE SHAFT OF THE BALLOON - NO EXCESSIVE FORCE WAS USED. NO DAMAGE WAS NOTED ON THE DEVICE PACKAGING. THE BOX THAT THE DEVICE CAME IN WAS INTACT. THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. NO CLEANING AGENTS WERE USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED WITH CHLOROPREP PRIOR TO PRODUCT PLACEMENT. THE DEVICE WAS REPLACED WITH THE SAME PRODUCT ID ON THE SAME DAY AND IT RESOLVED THE ISSUE. THE FINAL PATIENT OUTCOME WAS STABLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13061319 ↗
• MalfunctionDec 7, 2021Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Device Fell; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Device Fell

  ACCORDING TO THE REPORTER, PRIOR TO USE, DURING REMOVAL OF THE DEVICE FROM THE PROTECTIVE PACKAGING, THE DISTAL SLEEVE/ PROTECTIVE PACKAGING AROUND BALLOON WAS TOO TIGHT, IT CAUSED THE BALLOON TO COME OFF FROM THE SHAFT, NO EXCESSIVE FORCE USED AND THE DETACHMENT WAS SPONTANEOUS. THE PRODUCT WAS NOT USED, SET IT TO SIDE AS IT WAS DEFECTIVE, IT WAS REPLACED WITH ANOTHER BALLOON (COMPETITOR¿S BRAND) ON THE SAME DAY OF THE EVENT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO DAMAGE TO THE DEVICE'S BOX AND PACKAGING AND NOTHING UNUSUAL OBSERVED ON THE DEVICE ASIDE FROM REPORTED ISSUE. THE DEVICE WAS NOT REPAIRED, NO LEAK, NO CLEANING AGENT USED, AND NO LUER ADAPTER ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12952852 ↗
• MalfunctionDec 6, 2021Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Material Deformation; Device Fell; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Material Deformation; Device Fell

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING PREPARATION OF THE DEVICE IN VITRO, THE TECH DID TAKE OFF BALLOON PROTECTIVE SLEEVE/COVER BEFORE THE PIN, LOT OF RESISTANCE ENCOUNTERED, EXCESSIVE FORCE USED, AND THE BALLOON SNAPPED NEAR THE EXIT PORT MAKING THE BALLOON UNUSABLE FOR THE PROCEDURE. THERE WAS A BEND AT THE DISTAL END OF THE DEVICE¿S SHAFT, THE BEND WAS UNNOTICED IN THE PACKAGING AND THEY WERE NOT SURE IF THE BEND WAS PRESENT PRIOR TO REMOVING THE PIN. A COMPETITOR¿S BALLOON WAS USED ON THE SAME DAY/CASE BY THE DOCTOR IN THE DEFECTIVE BALLOON¿S PLACE, THE PROCEDURE WAS COMPLETED, NO OTHER PROBLEMS ENCOUNTERED AND THE ANGIOPLASTY WAS SUCCESSFUL. THE DEVICE WAS NOT REPAIRED, NO LEAK, TEGO WAS NOT UTILIZED AND NO LUER ADAPTER ISSUE. THE BOX AND THE PACKAGING WERE NOT DAMAGED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12945687 ↗
• MalfunctionNov 24, 2021Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component; Device Fell

  ACCORDING TO THE REPORTER, AFTER SEVERAL INFLATIONS, AT THE END OF THE PROCEDURE, WHEN THE CATHETER WAS BEING REMOVED FROM THE PATIENT, THE CATHETER SHEARED OFF WHILE BEING REMOVED FROM THE 6 FRENCH MERIT SHEATH (NO EXCESSIVE FORCE USED). THEY WERE ABLE TO RETRIEVE THE ENTIRE BALLOON AS IT WAS STUCK INSIDE OF THE SHEATH - BALLOON COMPLETELY BROKEN OFF FROM THE CATHETER SHAFT. KELLY CLAMP WAS USED TO RETRIEVE THE DETACHED ITEM WITH NO ADDITIONAL MEDICAL INTERVENTION REQUIRED IN RETRIEVING. NOTHING UNUSUAL WAS OBSERVED PRIOR TO USE. THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. NO CLEANING AGENT WAS USED ON THE DEVICE. USUAL PREP WAS DONE ON THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. 6 FRENCH MERIT SHEATH AND .035 GUIDEWIRE WERE BEING UTILIZED WITH THE DEVICE. FLUSHING WAS PERFORMED PER IFU (INSTRUCTION FOR USE) WITH NO ISSUES IDENTIFIED. THE BALLOON WAS INFLATED WITH AN INFLATION DEVICE AND THE INFLATION FLUID USED WERE CONTRAST AND SALINE SOLUTION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. IT WAS SAID THAT THE CATHETER WAS INSIDE THE PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868198 ↗
• MalfunctionNov 10, 2021Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component; Device Fell

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE TECHNICIAN WAS REMOVING THE PROTECTIVE SLEEVE AND WHEN GENTLY PULLING, THE BALLOON PULLED OFF AND BROKE COMPLETELY (NO EXCESSIVE FORCE WAS USED). IT WAS SAID THAT THE BALLOON WAS DETACHED FROM THE SHAFT AND THE CATHETER WAS UNABLE TO BE USED IN THE PROCEDURE. NO DAMAGE WAS NOTED ON THE DEVICE PACKAGING. THE BOX THAT THE DEVICE CAME IN WAS INTACT. THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. NO CLEANING AGENT WAS USED ON THE DEVICE. THERE WAS NO LUER ADAPTER ISSUE. A STANDARD PREP TECHNIQUE WAS DONE ON THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSION WAS REQUIRED. NO MEDICAL INTERVENTION/TREATMENT WAS PROVIDED DUE TO THE EVENT. THE CATHETER WAS REPLACED WITH THE SAME LOT NUMBER ON THE SAME DATE AS SOON AS THE BALLOON BROKE. THE SAID REPLACEMENT RESOLVED THE ISSUE AND THE PROCEDURE WAS COMPLETED BUT THAT BALLOON ALSO BROKE AT THE END OF THE CASE WHICH WAS REPORTED SEPARATELY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787549 ↗
• MalfunctionOct 21, 2021Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Device Fell; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Device Fell

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE BALLOON WAS PULLED FROM THE PACKAGE AND THE PROTECTIVE BALLOON COVER AND THE METAL PIN WERE REMOVED (PROTECTIVE SHEATH WAS VERY DIFFICULT TO REMOVE SO EXCESSIVE FORCED WAS USED). WHEN THE DOCTOR PUT IT OVER A 0.35 WIRE FROM COMPETITOR, THE BALLOON WOULD NOT ENTER THE PATIENT AND THAT WAS WHEN HE NOTICED THAT THE BALLOON HAD SEVERED/DETACHED AT THE METAL THIRD PORT AND WAS LYING ON THE STERILE FIELD. IT WAS SAID THAT WHEN IT GOT TO THE PATIENTS SKIN, THERE WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE, NO INTRODUCER SHEATH WAS USED. ALSO, THE DEVICE WAS NEVER ENTERED TO THE PATIENT AS THE TIP WAS TOO BLUNT FROM THE BALLOON NOT BEING ATTACHED. THE PROCEDURE NEVER GOT TO THE POINT OF INFLATING THE BALLOON. THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. SALINE WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED WITH CHLORAPREP PRIOR TO PRODUCT PLACEMENT. FLUSHING WAS PERFORMED PER IFU (INSTRUCTION FOR USE) AND THE RESULTS WAS NORMAL AS IT WAS FLUSHED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO DETACHED PORTION OF DEVICE IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12673040 ↗
• MalfunctionSep 29, 2021Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Device Fell; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Device Fell

  ACCORDING TO THE REPORTER, THE SCRUB TECH WAS REMOVING THE PROTECTIVE SLEEVE FROM THE CATHETER AND IT GOT STUCK ON THE SHAFT AND WHEN THE TECH WAS PULLING IT OFF, IT RIPPED/BROKE THE CATHETER SHAFT DISTAL END INTO TWO. THE DOCTOR HAD SWITCHED TO COMPETITOR'S BALLOON. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12551222 ↗
• MalfunctionOct 24, 2020Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Device Fell; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Device Fell

  ACCORDING TO THE REPORTER, THERE WAS NO DAMAGE NOTED TO THE BALLOON, BUT WHEN THE BALLOON WAS PREPARED, AND THE PROTECTIVE SHEATH WAS PULLED OFF OF THE CATHETER PRIOR TO THE PROCEDURE OR PRIOR TO USING ON THE PATIENT, THE BALLOON DETACHED FROM THE CATHETER SHAFT; THE PRODUCT WAS NO LONGER USED. THE PHYSICIAN USED ANOTHER PRODUCT (ENTIRE UNIT) FROM THE SAME MANUFACTURER TO COMPLETE THE PROCEDURE. THERE WAS NO DAMAGE TO THE DEVICE'S BOX AND PACKAGING. THE PRODUCT/KIT WAS STILL SEALED UPON RECEIPT. THERE WAS NO EXCESSIVE FORCE USED TO PULL/TAKE OUT THE PRODUCT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, AND FLUSHING WAS NOT DONE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE, AND THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10731679 ↗
• MalfunctionJul 31, 2020Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component; Device Fell

  ACCORDING TO THE REPORTER, DURING THE INFLATION OF THE BALLOON, IT DISLODGED FROM THE CATHETER. THEY WERE ABLE TO RETRIEVE THE BALLOON WITHOUT ANY INCIDENT TO THE PATIENT. IT WAS ALSO STATED THAT THE BALLOON WAS STUCK IN THE SHEATH OF POST REMOVAL FROM THE PATIENT AND THEY HAD TO HAVE AN ADDITIONAL STICK FOR SHEATH ACCESS ON THE PATIENT. THERE WERE NO OTHER DEFECTS NOTED ON THE DEVICE. THERE WAS AN OCCLUSION AND THERE WAS NO PACKAGING DAMAGE THAT MIGHT HAVE CONTRIBUTED TO THE REPORTED ISSUE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND IT WAS USED SUCCESSFULLY. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS PERFORMED. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO BLOOD LOSS. BLOOD TRANSFUSION WAS NOT NEEDED AND THERE WAS NO MEDICAL INTERVENTION DONE TO THE PATIENT. THE INSERTION SITE WAS TREATED WITH CHLOROPREP PRIOR TO PRODUCT PLACEMENT AND A SNARE WAS USED TO GRAB THE DETACHED BALLOON/RETRIEVED THE TIP OF THE BALLOON. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, SALINE WAS USED AS A CLEANING AGENT ON THE DEVICE, TEGO WAS NOT UTILIZED, THERE WAS NO LUER ADAPTER ISSUE, THERE WAS NO ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOC

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10351401 ↗
• MalfunctionJun 5, 2020Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component; Device Fell

  ACCORDING TO THE REPORTER, AN 8MM BALLON WAS BEING USED TO DECLOT. THE BALLOON WAS INSERTED THROUGH A SHEATH AND THE ANGIOPLASTY WAS PERFORMED, BUT WHEN THE PHYSICIAN TRIED TO REMOVE THE BALLOON IT WAS STUCK. NEGATIVE PRESSURE AND FORCE WERE APPLIED TO ATTEMPT REMOVAL, BUT THE BALLOON HEAD DETACHED FROM THE CATHETER AND BECAME STUCK IN THE SHEATH. THE SHEATH WAS REMOVED TO RETRIEVE THE BALLOON. A 7MM CATHETER WAS THEN USED ALSO WITH A SHEATH, AND BECAME STUCK. THE SHEATH WAS REMOVED WITH THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10124089 ↗
• MalfunctionJun 5, 2020Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Device Fell; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Device Fell

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS TAKEN OUT OF THE BOX ON THE PREPARATION TABLE, THE BALLOON HEAD CAME OFF THE CATHETER WHEN THE WIRE MANDREL AND BALLOON PROTECT COVER WAS PULLED OUT NORMALLY. NOTHING UNUSUAL WAS DONE PRIOR TO THE BALLOON BEING OPENED AND NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT AND THERE WAS NO DAMAGE TO THE DEVICE'S BOX OR PACKAGING. THE DEVICE WAS NO LONGER USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10124050 ↗
• MalfunctionJun 5, 2020Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component; Device Fell

  ACCORDING TO THE REPORTER, WHILE REMOVING THE 8-MM BALLOON AFTER DOING AN UPPER ARM STENOSIS WHEREIN THE LESION WAS EFFACED, RESISTANCE WAS NOTED. THE PHYSICIAN CONTINUED TO PULL (EXCESSIVE FORCE WAS NOT APPLIED) AND THE BALLOON BROKE OFF AT THE PROXIMAL END OF THE THIRD PORT INFUSION SITE JUST PROXIMAL TO THE BALLOON. IT WAS STATED THAT HALF OF THE DEVICE WAS IN THE PHYSICIAN'S HANDS AND THE OTHER HALF WAS STUCK IN THE 6F MEDICAL SHEATH (FROM A COMPETITOR'S) USED. IT WAS ALSO STATED THAT OCCLUSION WAS FELT WHILE PULLING THE BALLOON THROUGH THE 6F SHEATH. IT WAS ALSO NOTED THAT THE PHYSICIAN INITIALLY UTILIZED A 5-MM BALLOON FOR A JUXTA ANASTOMOSIS WHICH WAS SUCCESSFUL. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, AND NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. IT WAS NOTED THAT FLUSHING WAS PERFORMED PRIOR TO INSERTION, AND THE BALLOON AND THE THIRD PORT WORKED PROPERLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10123997 ↗