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

Model Number	VA5074
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that during preparation of a angioplasty procedure, the pta balloon shaft allegedly cracked.There was no reported patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: one vaccess pta dilatation catheter has returned for evaluation.On the visual evaluation of the device a circumferential break at the catheter shaft right below the proximal glue joint and exposing the inner guidewire lumen.All the anomalies was noted on the microscopic observation.No other anomalies noted and no functional performed due to condition of the device.The investigation is confirmed for the break, as a circumferential break was noted to the device during evaluation.A definitive root cause for the break 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: b5, g3, h11: h6 (method, result and conclusion), h11: section a through f ¿ the information provide 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.H3 other text : see h10.
Event or Problem Description
It was reported that during preparation of a angioplasty procedure, the pta balloon shaft allegedly cracked.It was further reported that the procedure was completed using another device.There was no patient contact.

• Brand Name: VACCESS PTA DILATATION 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: 11320421
• Report Number: 2020394-2021-00234
• Device Sequence Number: 3283933
• Product Code: LIT
• UDI-Device Identifier: 00801741059698
• UDI-Public: (01)00801741059698
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K111850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2021

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: VA5074
• Device Catalogue Number: VA5074
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 06/02/2021
• 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