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

Model Number	U3513054
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
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 returned for evaluation.No specific anomalies noted on the visual evaluation.On the functional testing of the returned device upon inflation using a in-house presto inflation device the balloon started leaking, upon microscopic observation it was noted a longitudinal balloon rupture.No further functional testing performed.Therefore, the investigation for the reported leak was confirmed as the balloon started leaking from the longitudinal rupture during the functional testing.The investigation was also confirmed for identified balloon rupture as longitudinal balloon rupture noted on the returned device under microscopic observation.Two photos were also reviewed.Two photos shows the catheter into a coiled formed and the balloon noted to be in deflated position, no damage noted on the catheter or balloon.No specific anomalies noted.Therefore, based on the photo review, the reported leak could not be confirmed as no evidence leak noted on submitted photos.A definitive root cause for the reported leak and identified balloon rupture could not be determined based upon the provided information.Labeling 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: 01/2023).
Event or Problem Description
It was reported that during an angioplasty procedure of the lower limb through the right femoral artery, the device allegedly failed to inflate causing leakage.It was further reported that 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 85281
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12966007
• Report Number: 2020394-2021-02046
• Device Sequence Number: 4415877
• Product Code: LIT
• UDI-Device Identifier: 00801741092671
• UDI-Public: (01)00801741092671
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2021

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: U3513054
• Device Catalogue Number: U3513054
• Device Lot Number: CMEP0275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 12/09/2021
• 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