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

Catalog Number CQ75124

Device Problems Deflation Problem (1149); Product Quality Problem (1506); Difficult to Remove (1528); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2014

Event Type  malfunction  

Event Description

It was reported that the pta balloon would not deflate.The balloon catheter was difficult to remove through the sheath; therefore, the catheter and sheath were removed together as a single unit.No further treatment was provided.There was no reported pt 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 not been returned to the mfr for eval.The investigation is currently underway.

Manufacturer Narrative

The lot number has been provided and the lot device history records have been reviewed the lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported for this lot number and issue to date.The device was returned and images were provided for review.The investigation is confirmed for deflation issues as the balloon was unable to deflate due to the glue bullet being lodged in the outer catheter shaft.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.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 were present (i.E., distal tip of sheath was flared out).The evaluation found the glue bullet was lodged within the catheter shaft, blocking the inflation/deflation ports.Additionally, the glue bullet appeared to be improperly formed.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 has been identified as manufacturing related and corrective action has been implemented.Patient identifiers are unknown/unobtainable despite numerous requests for that information.The current ifu (instructions for use) adequately captures balloon deflation issues and retraction issues.

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 international representative 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 international representative did not have any additional details to provide at this time.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.

• 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: 4436262
• MDR Text Key: 16994624
• Report Number: 2020394-2015-00010
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K083657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,company representati
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2014

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: 05/31/2017
• Device Catalogue Number: CQ75124
• Device Lot Number: REYE2018
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/15/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2014
• Initial Date FDA Received: 01/14/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/25/2015; 11/10/2015
• 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