OptiCross 35 H7493932800350Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 08714729984542), received between Sep 4, 2020 and Sep 9, 2026 — classified as 1 injury, 33 malfunctions.

The most frequently reported specific device problem is “Material Perforation” (13 reports).

1 FDA recall record name this device's identifier.

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 16, 2026.

Recalls naming this device

1. Aug 24, 2020Terminated

   Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length markings near the proximal end of the catheter shaft can flake off when the device is manipulated. No patient harm has been reported to date. The most common potential adverse health consequence would be prolonged procedure to exchange the catheter for another as this potential issue is observable and has occurred outside of the patient's body. The most server health consequence that is reasonably expected to occur if a catheter with this potential issue is used is embolization which would result of the flaking marks advance while flushing the catheter. All recalled devices should be returned to Boston Scientific.

   Z-0181-2021 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Incorrect Measurement; Device Displays Incorrect Message; Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50700092 ↗
• MalfunctionDec 11, 2025Material Perforation; Material Perforation

  IT WAS REPORTED THAT A HOLE IN THE CATHETER WAS OBSERVED. THE OPTICROSS PERIPHERAL IMAGING CATHETER WAS SELECTED FOR THE ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING INSERTION, A HOLE WAS NOTED IN THE CATHETER WHILE IT WAS BEING ADVANCED OVER THE WIRE. THE DEVICE WAS DISCARDED AND REPLACED WITH A NEW CATHETER TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23782014 ↗
• MalfunctionOct 15, 2025Nonstandard Device; Detachment of Device or Device Component; Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS 35 IMAGING CATHETER WAS SELECTED FOR USE IN THE ULTRASOUND EXAMINATION. DURING WITHDRAWAL, A SILVER SPRING WIRE EMERGED AND BROKE WHILE THE CATHETER WAS BEING PULLED OUT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279260 ↗
• MalfunctionAug 28, 2025Material Perforation; Connection Problem; Material Perforation; Connection Problem

  IT WAS REPORTED THE CATHETER WAS PERFORATED BY THE GUIDEWIRE. DURING USE OF THE OPTICROSS 35 CATHETER, WHEN BEING LOADED OVER THE AMPLATZ WIRE, IT PERFORATED THE SIDE OF THE CATHETER. THE DEVICE NEVER ENTERED THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22917828 ↗
• MalfunctionJun 3, 2025Contamination; Difficult to Open or Remove Packaging Material; Contamination; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE DEEP VEIN. AN 8F OPTICROSS 35 CATHETER WAS SELECTED FOR A VENOUS CASE. HOWEVER, DURING THE PREPARATION OF THE DEVICE, DIFFICULTY WAS NOTED IN OPENING THE INNER PACKAGING. CONSEQUENTLY, THE CATHETER WAS ACCIDENTALLY DROPPED ON THE FLOOR AND GOT CONTAMINATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22133889 ↗
• MalfunctionApr 17, 2025Material Integrity Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MATERIAL TWIST OCCURRED. AN OPTICROSS 35 WAS SELECTED FOR USE IN A VENOGRAM. DURING PREPARATION, THE CATHETER WAS ATTACHED TO THE SLED. HOWEVER, WHEN THE IMAGING WAS TURNED ON FOR A TEST, THE ENTIRE CATHETER UNCOILED. THE PROCEDURE WAS COMPLETED WITH A NEW CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857710 ↗
• MalfunctionJan 9, 2025Detachment of Device or Device Component; Material Deformation; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Material Deformation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13DEC2024. IT WAS REPORTED THAT THE SHEATH CRUMBLED AND KINK. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A OPTICROSS 35 VASCULAR IMAGING CATHETER WAS USED IN DEEP VEIN THROMBOSIS ILIAC PROCEDURE. HOWEVER, WHEN THE CATHETER WAS PREPARED, IT WAS NOTICED THAT THE SHEATHING OF THE IVUS DEVICE WAS SEPARATED, CRUMBLED AND KINKED. THE PROCEDURE WAS COMPLETED WITH A NEW ONE. NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED TORN IMAGING WINDOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114375 ↗
• MalfunctionDec 17, 2024Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT THE GUIDEWIRE PUNCTURED THE CATHETER. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND VERY TIGHTLY CALCIFIED SUBCLAVIAN ARTERY. AN OPTICROSS 35 AND AMPLATZ GUIDEWIRE WERE SELECTED FOR ARTERIAL INTERVENTION. HOWEVER, WHILE ADVANCING THE CATHETER OVER THE WIRE, THE BACK END OF THE WIRE EXITED THE SIDE OF THE SHAFT OF THE CATHETER, BASICALLY POKING A HOLE THROUGH THE WALL. THE DEVICE WAS REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20953983 ↗
• MalfunctionOct 1, 2024Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS 35 IVUS VASCULAR IMAGING CATHETER WAS SELECTED TO TREAT A PATIENT WITH PERIPHERAL ARTERY DISEASE (PAD) / PERIPHERAL VASCULAR DISEASE (PVD). DURING THE PREPARATION, THE GUIDEWIRE PUNCTURED A HOLE THROUGH THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE PROVIDED. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE PIERCED THROUGH THE CATHETER DISTAL TO THE TRANSDUCER. THE ISSUE OCCURRED PRIOR TO THE PROCEDURE DURING PREPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20345671 ↗
• MalfunctionSep 26, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT PROCEDURE WAS CANCELLED. AN OPTICROSS 35 WAS SELECTED FOR USE. THERE WAS AN INITIAL IMAGE UPON PREPARATION. HOWEVER, DURING THE PROCEDURE, UPON SECOND RUN ON BILATERAL SIDE, NO IMAGE WAS PRESENT. THE PROCEDURE WAS CANCELLED AS IT WAS THE LAST CATHETER ON THE SHELF. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20311203 ↗
• MalfunctionJul 17, 2024Material Perforation; Material Perforation

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT ILIAC VEIN. AN OPTICROSS 35 IMAGING CATHETER WAS CHOSEN FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, WHILE ADVANCING THE CATHETER OVER THE GUIDEWIRE, THE BACK END OF THE WIRE PUNCTURED THROUGH THE SIDEWALL OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19766513 ↗
• MalfunctionJul 5, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE RIGHT ILIAC VEIN. THE OPTICROSS 35 IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, AFTER REMOVING THE IVUS CATHETER FROM THE LEFT ILIAC VEIN AND ADVANCING IT OVER TO THE RIGHT ILIAC VEIN, IT WAS REMOVED FROM THE RIGHT AND POSITIONED UP THE LEFT WIRE TO REFERENCE THE LEFT CONFLUENCE. THE OPTICROSS CATHETER BECAME STUCK ON THE WIRE. THE WIRE AND OPTICROSS CATHETER WERE REMOVED TOGETHER AND REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19682956 ↗
• MalfunctionMay 20, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS 35 IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE IVUS CATHETER BECAME STUCK AND HAD TO BE REMOVED ALONG WITH THE WIRE BY FLUSHING AND USING A WET WIRE TECHNIQUE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352444 ↗
• MalfunctionApr 24, 2024Material Deformation; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Material Deformation; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS 35 IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE IVUS CATHETER BECAME TWISTED AND KINKED WHILE PROGRESSING FORWARD WITH THE MOTOR DRIVE UNIT TURNED ON. THE PHYSICIAN WAS ABLE TO REMOVE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19176849 ↗
• MalfunctionJan 31, 2024Poor Quality Image; Material Perforation; Poor Quality Image; Material Perforation

  IT WAS REPORTED THAT CATHETER ISSUES OCCURRED. THE PATIENT PRESENTED FOR A VENOUS INTERVENTION. AS THE OPTICROSS 35 IMAGING CATHETER WAS BEING INSERTED OVER AN AMPLATZ SUPER STIFF GUIDEWIRE, THE BACK OF THE WIRE CAME OUT THE SIDE OF THE OPTICROSS CATHETER ABOUT MID SHAFT. THE OPTICROSS WAS REMOVED AND WHEN ANOTHER OPTICROSS 35 WAS BEING INSERTED, THE AMPLATZ WIRE CAME OUT THE SIDE OF THAT CATHETER ABOUT 4 INCHES BEFORE THE EXIT PORT. THE CASE WAS CONTINUED WITH THE DAMAGED CATHETER AND THE VESSEL WAS ABLE TO BE PARTIALLY IMAGED BEFORE IMAGING WAS LOST. THE CATHETER WAS REMOVED INTACT AND THE CASE CONTINUED WITHOUT INTRAVASCULAR ULTRASOUND. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18615989 ↗
• MalfunctionJan 31, 2024Material Perforation; Material Perforation

  IT WAS REPORTED THAT CATHETER ISSUES OCCURRED. THE PATIENT PRESENTED FOR A VENOUS INTERVENTION. AS THE OPTICROSS 35 IMAGING CATHETER WAS BEING INSERTED OVER AN AMPLATZ SUPER STIFF GUIDEWIRE, THE BACK OF THE WIRE CAME OUT THE SIDE OF THE OPTICROSS CATHETER ABOUT MID SHAFT. THE OPTICROSS WAS REMOVED AND WHEN ANOTHER OPTICROSS 35 WAS BEING INSERTED, THE AMPLATZ WIRE CAME OUT THE SIDE OF THAT CATHETER ABOUT 4 INCHES BEFORE THE EXIT PORT. THE CASE WAS CONTINUED WITH THE DAMAGED CATHETER AND THE VESSEL WAS ABLE TO BE PARTIALLY IMAGED BEFORE IMAGING WAS LOST. THE CATHETER WAS REMOVED INTACT AND THE CASE CONTINUED WITHOUT INTRAVASCULAR ULTRASOUND. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18615987 ↗
• MalfunctionJan 22, 2024Poor Quality Image; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Poor Quality Image; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE PATIENT PRESENTED WITH 60% ILIAC VEIN STENOSIS. THE OC35 IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE NON-CALCIFIED AND NON-TORTUOUS TARGET LESION. AS THE CATHETER WAS BEING MOVED TO POSITION FOR IMAGING THE VESSEL, THE TELESCOPE HUB AND TELESCOPE CATHETER BECAME DISCONNECTED AND AT THE SAME TIME, A HALO WAS NOTICED AROUND THE IMAGE ON THE SCREEN. THE DEVICE WAS REMOVED, AND THE PROCEDURE COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18557817 ↗
• MalfunctionAug 10, 2023Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE PATIENT PRESENTED WITH MAY-THURNER SYNDROME FOR A VENOGRAM PROCEDURE. VASCULAR ACCESS WAS OBTAINED VIA BILATERAL FEMORAL VEIN APPROACH WITH UNKNOWN 8F SHEATHS. THE 79% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED VESSEL COMPRESSING THE LEFT ILIAC VEIN. AFTER AN AMPLATZ SUPER STIFF GUIDEWIRE WAS INSERTED, AN OPTICROSS 35 IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, AFTER THE CATHETER IMAGED THE TARGET LESION WITH NO ISSUES, THE CATHETER WAS PLACED BACK ON THE RIGHT SIDE TO RE-IMAGE FOR STENT LANDMARK. HOWEVER, UPON TRYING TO REMOVE THE CATHETER, IT BECAME STUCK ON THE WIRE. RE-FLUSHING DID NOT RESOLVE THE ISSUE. THE OPTICROSS CATHETER AND AMPLATZ WIRE WERE THEN REMOVED TOGETHER. THE WIRE SPLIT THE CATHETER LUMEN WHEN ATTEMPTED TO REMOVE OUTSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME OPTICROSS CATHETER AND AMPLATZ WIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17504113 ↗
• MalfunctionApr 13, 2023Material Perforation; Material Perforation

  IT WAS REPORTED THAT CATHETER PERFORATION OCCURRED. THE PATIENT PRESENTED FOR A BILATERAL VENOUS CASE. THE OPTICROSS 35 IMAGING CATHETER WAS ADVANCED OVER AN AMPLATZ SS GUIDEWIRE FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. THE STIFF END OF THE AMPLATZ EXITED THROUGH THE SIDE OF THE OPTICROSS CREATING A HOLE IN THE CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER OPTICROSS 35 CATHETER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16734471 ↗
• MalfunctionDec 7, 2022Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE PATIENT PRESENTED WITH LOWER EXTREMITY SWELLING FOR A VENOGRAM AND STENTING PROCEDURE. THE 66% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED VESSEL. AN 8F SHEATH WAS INSERTED OVER A 0.035 NON-BOSTON SCIENTIFIC GUIDEWIRE. THE OPTICROSS 35 IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION AND IMAGING WAS PERFORMED WITHOUT INCIDENCE. WHEN AN ATTEMPT WAS MADE TO REMOVE THE CATHETER, THE CATHETER BECAME STUCK ON THE WIRE AND THE DEVICES HAD TO BE REMOVED TOGETHER AS A UNIT. AFTER REMOVAL, IT WAS NOTED THAT THE CATHETER WAS SHREDDED MID SHAFT AND STUCK ON THE WIRE. SINCE NECESSARY IMAGING HAD ALREADY BEEN GATHERED, THE PROCEDURE CONTINUED. A STENT WAS DEPLOYED WITHOUT ANY ISSUES TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15934243 ↗
• MalfunctionOct 27, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE PATIENT PRESENTED WITH MAY-THURNER SYNDROME FOR A VENOGRAM. THE TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND NON-CALCIFIED ILIAC VEIN. THE OC35 IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. WHEN THE DEVICE WAS BEING REMOVED OVER A NON-BOSTON SCIENTIFIC GUIDEWIRE, THE DEVICE BECAME STUCK ON THE WIRE AND THE DEVICES HAD TO BE REMOVED TOGETHER THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15686456 ↗
• MalfunctionSep 28, 2022Material Perforation; Material Perforation

  IT WAS REPORTED THAT SHAFT PERFORATION OCCURRED. THE OPTICROSS 35 WAS SELECTED FOR USE. WHILE LOADING THE CATHETER OVER THE NON-BOSTON SCIENTIFIC WIRE, THE WIRE PIERCED THROUGH THE SHAFT OF THE CATHETER ABOUT 5CM FROM THE TIP. THIS ALLOWED AIR INTO THE SYSTEM AND IMAGE QUALITY WAS POOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15496708 ↗
• MalfunctionJul 12, 2022Material Perforation; Material Perforation

  IT WAS REPORTED THAT DEVICE PERFORATION OCCURRED. THE PATIENT PRESENTED FOR A LOWER EXTREMITY VENOUS INTERVENTION. WHEN THE OPTICROSS35 IMAGING CATHETER WAS BEING LOADED ONTO THE GUIDEWIRE, THE WIRE PUNCTURED THROUGH THE LUMEN OF THE CATHETER AND EXITED CLOSE TO THE DISTAL END OF THE CATHETER AND NOT THROUGH THE WIRE LUMEN HUB ON THE PROXIMAL END. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14988671 ↗
• MalfunctionApr 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. THE OPTICROSS OC35 PERIPHERAL IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. AS THE CATHETER WAS BEING USED, THE OUTER SHAFT SEPARATED. THE CASE WAS ABLE TO BE COMPLETED BUT THE IMAGING WAS BLURRY. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14054359 ↗
• MalfunctionMar 18, 2022Material Perforation; Material Perforation

  IT WAS REPORTED THAT A CATHETER PERFORATION OCCURRED. THE PATIENT PRESENTED WITH LEG SWELLING FOR A VENOGRAM WITH A BILATERAL ILIAC STENT. AS THE OC35 PERIPHERAL IVUS CATHETER WAS BEING LOADED ON THE GUIDEWIRE, THE BACK END OF THE WIRE PUNCTURED A HOLE IN THE CATHETER INSTEAD OF COMING OUT THE HUB. THE DEVICE WAS REMOVED FROM THE WIRE AND THE PROCEDURE COMPLETED SUCCESSFULLY WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13805344 ↗