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

Catalog Number CQ7588

Device Problems Deflation Problem (1149); Product Quality Problem (1506); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2014

Event Type  malfunction  

Event Description

It was reported that the pta balloon ruptured during use in a dialysis fistula and then the catheter was difficult to retract through the introducer sheath.There was no reported pt injury.

Manufacturer Narrative

A manufacturing review was conducted.The lot met all release criteria.This is the only complaint reported to date for this lot number and this failure mode.The device was returned.The investigation is confirmed for deflation issues as the glue bullet was found lodged inside the outer shaft.The investigation is also confirmed for retraction problems, as the balloon was unable to be removed from the sheath and physical evidence of retraction issues was present (distal tip of sheath ws flared out).The definitive root cause could not be determined based upon the available information.

Manufacturer Narrative

The evaluation found the glue bullet was lodged within the catheter shaft, partially blocking the inflation /deflation ports.Additionally, the glue bullet did not appear perpendicular to the polyamide surface, which may have contributed to it becoming lodged.The root cause for the deflation issues is related to the glue bullet becoming lodged within the catheter shaft, which led to the retraction issues.The root cause for the improperly formed glue bullet is manufacturing related.

Manufacturer Narrative

To ensure compliance to 21 cfr 803.50 a retrospective review of this file was conducted to determine if good faith efforts were made to obtain the required information and/or an explanation of why any required information was not provided.Multiple follow up attempts were made with the facility to obtain any information pertaining to the patient, product, and/or procedural details (e.G.Date of the event, relevant test data, relevant history, lot #, catalog #, implant and/or explanted dates, and concomitant product(s) or therapy) that were not previously obtained during the initial investigation.The report source did not have any additional details to provide at this time.

• Brand Name: CONQUEST PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 3850713
• MDR Text Key: 21489400
• Report Number: 2020394-2014-00099
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative,hea
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2014

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: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: CQ7588
• Device Lot Number: REXI0680
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/03/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/19/2014
• Initial Date FDA Received: 03/20/2014
• Supplement Dates Manufacturer Received: 09/30/2015; 09/30/2015
• Supplement Dates FDA Received: 08/14/2014; 10/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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