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

Model Number	RV135415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review was 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.(expiry date: 04/2019); (manufacturing date: 04/2016).The information provided by bard 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 bard.
Event or Problem Description
It was reported through the results of a clinical trial, that the superficial femoral artery was observed to have a grade b non-flow limiting dissection after pre-dilation with a percutaneous transluminal angioplasty (pta) balloon dilatation catheter.It was further reported that the diseased vessel was treated with two drug coated pta balloons and a grade c flow-limiting, dissection was observed after treatment.Reportedly, the pre-dilation device was used for post-dilation to resolve the dissection.There was no reported patient injury.

• Brand Name: RIVAL PTA BALLOON 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: 7928594
• Report Number: 2020394-2018-01831
• Device Sequence Number: 1798112
• Product Code: LIT
• UDI-Device Identifier: 00801741063435
• UDI-Public: (01)00801741063435
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 10/02/2018

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: RV135415
• Device Catalogue Number: RV135415
• Device Lot Number: GFAQ2797
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/02/2018
• 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: 76 YR
• Patient Weight: 70