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	08/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary: a complete manufacturing review could not be conducted, as the lot number was not reported for this device.The investigation is inconclusive for the reported balloon rupture and detachment, as the device was not returned for evaluation.The definitive root cause for the reported balloon rupture and detachment could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported that during an angioplasty procedure in the cephalic vein, the pta balloon allegedly ruptured on the first inflation attempt.It was further reported that there was detached material, and surgical intervention was required to retrieve the detached material.The patient was reportedly stable.

• 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: 9090178
• Report Number: 2020394-2019-03379
• Device Sequence Number: 14036755
• Product Code: DQY
• UDI-Device Identifier: 00801741121319
• UDI-Public: (01)00801741121319
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 09/19/2019

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/19/2019
• 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: Required Intervention
• Patient Age: 49 YR
• Patient Weight: 64