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

Model Number	US35130510
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	08/05/2021
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 ultrascore 035 pta dilatation catheter was received for evaluation.During visual evaluation, the sample appeared to have residue on the catheter shaft.No kinks noted to the catheter shaft, no anomalies to the luers and y-body.During functional evaluation, an in-house presto inflation device was used to inflate the balloon.No water was noted leaking from the catheter but the balloon did not inflate.The balloon was cut and no anomalies were noted to the portholes.The balloon was further examined by removing the strain relief cover and cracks were noted within the plastic proximal to the y-body.Under microscopic evaluation, cracks were noted distal to the y-body.No other functional testing was performed.Therefore the investigation is unconfirmed for the reported leak on catheter as no water leak was noted from the catheter during functional testing.Therefore, the investigation is confirmed for the identified material split, cut or torn as cracks were noted distal to the y-body during microscopic evaluation.A definitive root cause for the alleged leak on catheter and identified material split, cut or torn 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: 08/2022).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly leaked from the catheter.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: ULTRASCORE 035
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12580771
• Report Number: 2020394-2021-01832
• Device Sequence Number: 3289314
• Product Code: PNO
• UDI-Device Identifier: 00801741116773
• UDI-Public: (01)00801741116773
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K172571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2021

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: US35130510
• Device Catalogue Number: US35130510
• Device Lot Number: GFEV1274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1