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

Model Number	RV8056
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	09/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
It was reported that during an angioplasty procedure for arterial thrombosis in the left a/v forearm fistula, the pta balloon allegedly ruptured at 8 atm.It was further reported that the patient experienced excessive blood loss.Patient status is unknown.
Additional Manufacturer Narrative
After further review of the details provided by the complainant, it was identified that an uncomplicated balloon rupture occurred, there was no reported patient injury, and medical intervention was not required.The reported event is no longer reportable.
Event or Problem Description
It was reported that during an angioplasty procedure for arterial thrombosis in the left a/v forearm fistula, the pta balloon allegedly ruptured at 8 atm.It was further reported that the patient experienced excessive blood loss.Patient status is unknown.

• Brand Name: RIVAL 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: 9221895
• Report Number: 2020394-2019-04304
• Device Sequence Number: 2106716
• Product Code: DQY
• UDI-Device Identifier: 00801741063503
• UDI-Public: (01)00801741063503
• Combination Product (Y/N): N
• PMA/510(K) Number: K120722
• 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): 10/31/2019

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: RV8056
• Device Catalogue Number: RV8056
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 10/31/2019
• 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: 65 YR
• Patient Weight: 70