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

Model Number RV13556

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device was provided and a lot history review was performed.The device was not returned for evaluation, therefore the investigation is inconclusive for the alleged issue.The definitive root cause could not be determined.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model rv13556 pta balloon dilatation catheter allegedly experienced detachment of device.This information was received from one source.There was no patient contact.The patient is a (b)(6) year old male who's weight is unknown.

• Brand Name: RIVAL PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9198952
• MDR Text Key: 162627111
• Report Number: 2020394-2019-04019
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741063527
• UDI-Public: (01)00801741063527
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2019

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
• Device Operator: No Information
• Device Model Number: RV13556
• Device Catalogue Number: RV13556
• Device Lot Number: GFBX2534
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/16/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1