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

Model Number	U357574
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation; however, photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 08/2023).
Event or Problem Description
It was reported that during preparation of an angioplasty procedure, the pta balloon allegedly had foreign material inside the package.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: a sample was retuned for evaluation and no anomalies were noted to the device.The returned device was removed from the package but no signs of the foreign material was noted during the evaluation.No further functionality testing was conducted due to the nature of the complaint.One photo was reviewed by quality engineer.The photo shows a hair like foreign material found over the outer surface of the inflation luer, no other anomalies noted.Therefore, based on the photo review, the reported failure foreign material can be confirmed.However, the investigation will be inconclusive for the reported device contamination as there was no signs of the foreign material noted during evaluation although the photo attached was noted for the foreign material.A definitive root cause for the alleged foreign material could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4(expiry date: 08/2023).H11: section a through f - the information provided by bd represents all of 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.
Event or Problem Description
It was reported that during preparation of an angioplasty procedure, the pta balloon allegedly had foreign material inside the package.There was no patient contact.

• Brand Name: ULTRAVERSE 035 PTA CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11432044
• Report Number: 2020394-2021-00469
• Device Sequence Number: 3287407
• Product Code: LIT
• UDI-Device Identifier: 00801741093456
• UDI-Public: (01)00801741093456
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142261
• 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,Followup
• Report Date (Section B): 06/11/2021

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: U357574
• Device Catalogue Number: U357574
• Device Lot Number: CMEW0311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other