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

Catalog Number CQ7584

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2014

Event Type  malfunction  

Event Description

It was reported that the pta balloon did not inflate.There was no reported retraction difficulties.There was no reported patient injury.

Manufacturer Narrative

A further clinical review was performed and identified this event to be mdr reportable pursuant to 21 cfr part 803.A complete manufacturing review could not be performed as the lot number is unknown.The device was returned.The investigation is inconclusive for inflation issues, as the balloon was able to fully inflate; however, the glue bullet was found to be 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 improperly formed and lodged within the outer catheter shaft.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 current ifu(instructions for use) states: warnings: when the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated.If resistance is met during manipulation, determine the cause of the resistance before proceeding.Applying excessive force to the catheter can result in tip breakage or balloon separation.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.; tempe AZ
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: brett curtice ; 1625 west 3rd st.; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 4781442
• MDR Text Key: 5818879
• Report Number: 2020394-2015-00248
• 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,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/24/2014

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 Catalogue Number: CQ7584
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/11/2014
• 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
• 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