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

Catalog Number	U35130815
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	12/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure in the iliac artery via the femoral artery access, the pta balloon delivery tube was allegedly found to leak outward.The procedure was completed by using another device.There was no reported patient injury.
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 35 dilatation catheter was returned for evaluation.A tear on the catheter shaft was observed, and no other specific anomalies were observed during the visual evaluation.In the functional testing, the balloon was inflated on an in-house presto inflation device and water was noted to be leaking from the tear.Then the rubber strain relief was removed, and the catheter was clamped near the tear to identify any leak from the y-body.However, the clamping was unsuccessful, and the fluid was still leaking from the tear.Then the catheter was cut proximally near the tear and the distal portion of the device was clamped.Upon pressurization, water leaks only from the distal portion of the device which is clamped, not the y-body.No other functional testing was performed.Also, one video was reviewed.The video shows the balloon was been inflate with syringe, upon pressurization, leakage on the catheter shaft was observed, but the source of the leakage couldn't be observed on the submitted video.As submitted video confirms the leakage on the catheter shaft and the return sample identifies the catheter shaft tear causing the leakage from the tear upon functional testing.Hence, the investigation was confirmed for the reported leak and identified a catheter tear.A definitive root cause for the reported leak and identified a catheter tear could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.Expiration date: 06/2026.The information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• 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: 19341818
• Report Number: 2020394-2024-00650
• Device Sequence Number: 18314762
• Product Code: LIT
• UDI-Device Identifier: 00801741094224
• UDI-Public: (01)00801741094224
• 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): 05/15/2024

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 Catalogue Number: U35130815
• Device Lot Number: CMHU0416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 05/17/2024
• 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 Sex: Unknown