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

Catalog Number RV8044

Device Problems Inflation Problem (1310); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that the pta balloon would not inflate.The catheter was removed without incident and another balloon was used to perform the procedure.There was no report of pt injury.

Manufacturer Narrative

A further clinical review was performed and identified this event to be mdr reportable pursuant to 21 cfr part 803.The device history records have been reviewed with special attention to the raw materials, the subassemblies, the mfg process and the quality control testing.This lot met all release criteria.There was nothing found to indicate there was a mfg related cause for this event.This is the only complaint reported to date for this failure mode.The device was returned.The complaint investigation is confirmed for inflation issues.The investigation is also confirmed for foreign material present in the device, as an unk material was present inside the inflation port, preventing inflation of the balloon.It is unk whether the material inside the inflation port is glue/epoxy or how it got inside the inflation port.It is unlikely that the blockage is mfg related, as there are multiple mfg controls in place to prevent these types of issues.Based upon the available info, the definitive root cause for this event is unk.The rival pta balloon instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.The info provided by bard represents all of the known info at this time.Despite good faith efforts to obtain additional info, the complainant/ reporter was unable or unwilling to provide any further pt, product, or procedural details to bard.

• Brand Name: RIVAL PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804 204
• Manufacturer Contact: bryan vogel ; 1625 west 3rd st.; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 4781117
• MDR Text Key: 5819331
• Report Number: 2020394-2015-00359
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: RV8044
• Device Lot Number: GFYA3562
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/05/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1