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); Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/20/2015

Event Type  Injury  

Event Description

It was reported that the pta balloon would not deflate after the first inflation (atm unknown) in the right upper arm a/v fistula.Patient underwent additional medical intervention (a needle stick through the skin) to deflate the balloon.The balloon catheter was retracted through the sheath with difficulty.Another balloon was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

A manufacturing review was performed.The lot met all release criteria.The patient's weight was unobtainable.This is the first complaint reported to date for this lot number, for these failure modes.The device was returned.The investigation is inconclusive for deflation issues, as the balloon was unable to be functionally tested due to the glue bullet blocking the inflation/deflation port.The investigation is confirmed for a product quality issue, as the od of the glue bullet was too small, causing the glue bullet to become lodged within the outer catheter shaft.The investigation is also confirmed for retraction problems, as physical evidence of retraction issues were present (balloon bunched near distal tip).The evaluation found the glue bullet was lodged within the catheter shaft, blocking the inflation/deflation ports.The od of the glue bullet was too small and did not meet the minimum required specification.The root cause for the glue bullet becoming lodged in the catheter shaft is manufacturing related and likely caused the deflation 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 user facility to obtain any information pertaining to the patient, product, and/or procedural details (e.G.Relevant test data, relevant history, 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.The file was updated with an expiration date that was not previously reported.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: 4585132
• MDR Text Key: 5447438
• Report Number: 2020394-2015-00116
• 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: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: CQ75124
• Device Lot Number: REYI1183
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/09/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2015
• Initial Date FDA Received: 03/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR