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

Catalog Number CQ75124

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2015

Event Type  malfunction  

Event Description

It was reported that the pta balloon would not inflate beyond 15 atm in a subclavian in stent restenosis.The device was deflated and retracted through the sheath without difficulty.Another balloon was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

A further clinica review was performed and identified this event to be mdr 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 manufacturing related cause for this event.This is the only complaint reported for this lot number and issue to date.The device was returned.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.The evaluation found the glue bullet was lodged within the catheter shaft, partially blocking the inflation/deflation ports.The od of the glue bullet did not meet the minimum specifications.The root cause for the improperly formed glue bullet is manufacturing related.The root cause for the inflation issues is likely related to the glue bullet becoming lodged within the catheter shaft.The conquest instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.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
• Type of Device: DQY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: george james ; 1625 west 3rd st.; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 4780941
• MDR Text Key: 5816113
• Report Number: 2020394-2015-00376
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2015

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: 02/28/2017
• Device Catalogue Number: CQ75124
• Device Lot Number: REYB2251
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2015
• Initial Date FDA Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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