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

Catalog Number CQ7584

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

Patient Problems No Consequences Or Impact To Patient (2199); Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that after the first inflation at 20 atm, the pta balloon would not deflate.There was no reported retraction difficulty through the sheath.There was no reported patient injury.

Manufacturer Narrative

The lot number for the device has been provided.A review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation is currently underway.

Manufacturer Narrative

The device history records were reviewed and the lot met all release criteria.This is the only event reported to date for this lot number and failure mode.The device was returned for evaluation and an attempt was made to inflate the balloon with water using an tn-house inflation device, however, the balloon was unable to inflate.The balloon was cut at the proximal cone to examine the inflation/deflation ports.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 polyimide surface, which may have contributed to it becoming lodged.The root cause for the improperly formed glue bullet is manufacturing related.The root cause for the deflation issues is likely related to the glue bullet becoming lodged within the catheter shaft.Based on these results, the investigation is inconclusive for deflation issues, however, the investigation is confirmed for a product quality issue, as the glue bullet was found to be improperly formed and lodged within the outer catheter shaft.Operator awareness training regarding the glue bullet process was performed.The current ifu (instructions for use) lists warnings, precautions, and specific directions for use of the conquest pta dilatation catheter.

Manufacturer Narrative

The returned balloon appeared to be in its original folded configuration, indicating that the user likely had issues inflating and possibly deflating the balloon.The investigation is inconclusive for deflation issues as the balloon was unable to be inflated during functional testing.The investigation is confirmed for inflation issues, as the balloon was returned in what appeared to be its original folded configuration and the balloon could not be inflated during functional testing.

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 user facility 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 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 4209362
• MDR Text Key: 5042724
• Report Number: 2020394-2014-00429
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/27/2014

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: 05/31/2017
• Device Catalogue Number: CQ7584
• Device Lot Number: REYE0831
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/09/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/27/2014
• Initial Date FDA Received: 09/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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