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

Catalog Number CQ7584

Device Problems Inflation Problem (1310); Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2014

Event Type  malfunction  

Event Description

It was reported that the pta balloon would not inflate.There was no reported difficulty in retracting the device through the sheath.There was no reported pt injury.

Manufacturer Narrative

A further clinical review was performed and identified this event to be mfr reportable pursuant to 21 cfr part 803.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 mfg related cause for this event.This is the only complaint reported for this lot number and issue to date.The investigation is confirmed for inflation issues as the balloon was unable to inflate due to the glue bullet being lodged in the outer catheter shaft and blocking the inflation/deflation ports.The investigation is confirmed for a product quality issue, as the glue bullet was found to be lodged within the outer catheter shaft.Operator awareness training regarding the glue bullet process was performed.Inflation issues are adequately addressed in the current ifu.

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.This file was missing patient details.Email sent to international representative regarding patient information missing from the file.Multiple follow up attempts were made with the international representative to obtain any information pertaining to the patient details that were not previously obtained during the initial investigation.The hospital was not willing to provide any details in regards to the missing information.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 DILATION 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: 4781299
• MDR Text Key: 18001068
• Report Number: 2020394-2015-00227
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K083657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,company representative,for
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/03/2014

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: 11/30/2016
• Device Catalogue Number: CQ7584
• Device Lot Number: REXJ2424
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/22/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/24/2015
• Initial Date FDA Received: 04/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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