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

Model Number	VA8074
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/19/2019
Type of Reportable Event	Serious Injury
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 been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Medical device - expiry date: 05/2022.
Event or Problem Description
It was reported that during an angioplasty procedure of a venous outflow graft, the pta balloon allegedly ruptured and had detached material.It was further reported that the patient required additional hospitalization to retrieve the detached material.The patient is reportedly stable post procedure.
Event or Problem Description
It was reported that during an angioplasty procedure of a venous outflow graft, the pta balloon allegedly ruptured and had detached material.It was further reported that the patient required additional hospitalization to retrieve the detached material.The patient is reportedly stable post procedure.
Additional Manufacturer Narrative
H10: the device history records were reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.The device was returned for evaluation; device evaluation confirmed detachment of the device or a device component, but was inconclusive for material rupture as the balloon portion of the device was not returned.The definitive root cause for the reported issues could not be determined based upon available information.It is unknown whether patient or procedural issues contributed to the event.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4: (expiry date: (b)(6) 2022.

• 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: 9009481
• Report Number: 2020394-2019-03271
• Device Sequence Number: 2181747
• Product Code: DQY
• UDI-Device Identifier: 00801741121319
• UDI-Public: (01)00801741121319
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VA8074
• Device Catalogue Number: VA8074
• Device Lot Number: 93SD0072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 01/30/2020
• 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: Hospitalization
• Patient Age: 58 YR
• Patient Weight: 91