MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035; PTA BALLOON DILATATION CATHETER

Model Number	U35130108
Medical Device Problem Codes	Leak/Splash (1354); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one ultraverse 035 pta dilatation catheter was received for evaluation.During visual evaluation, a tear was noted on the catheter shaft.No kinks noted to the catheter shaft and no anomalies to the luers/y-body.During functional testing, an in-house presto inflation device was used to inflate the balloon and water was noted leaking from the tear on the catheter.One video was provided and reviewed.The video shows the ultraverse 035 catheter.During irrigation of the device, leak is noted at one of the geo markings of the catheter.However the specific cause of the leak could not be identified in the video.No other anomalies noted.Two photos were provided and reviewed.The first photo shows the front of the outer packaging of the ultraverse 035 catheter with the labeling corresponding to the device.The second photo shows the back of the outer packaging.Two ultrasound images were provided and reviewed.A vessel is shown in each image.It appears that either these are two different vessels or visualized at different planes, however there is no context to the images provided nor translation of the report below the images.The details and settings of the ultrasound cannot be determined from the provided images due to poor image quality.Therefore, the investigation is confirmed for the reported leak as liquid was noted leaking from the catheter shaft during irrigation of the device, from the provided video and during functional testing of the returned sample.The investigation is confirmed for the identified catheter tear as a tear was noted on the catheter shaft during visual evaluation of returned device.A definitive root cause for the alleged leak and identified catheter tear could not be determined based upon the available information.Labelling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.(expiry date: 08/2024).
Event or Problem Description
It was reported that during an angioplasty procedure, the device allegedly leaked from the marking band of the balloon body.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: ULTRAVERSE 035
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15190898
• Report Number: 2020394-2022-00651
• Device Sequence Number: 12265339
• Product Code: LIT
• UDI-Device Identifier: 00801741094729
• UDI-Public: (01)00801741094729
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: U35130108
• Device Catalogue Number: U35130108
• Device Lot Number: CMFW0203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 70 KG