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

Catalog Number CQ7588

Device Problems Break (1069); Product Quality Problem (1506); Retraction Problem (1536); Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); Insufficient Information (4580)

Event Date 04/15/2014

Event Type  malfunction  

Event Description

It was reported that the pta balloon dilation catheter shaft broke during retraction into the sheath.The catheter and sheath were removed as a single unit.There was no reported patient 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 been returned to the manufacturer for evaluation.The investigation is currently underway.

Manufacturer Narrative

A manufacturing review was performed and the lot met all release criteria.This is the only complaint reported to date for this lot number and issues.The device was returned lodged in a sheath that was severely bunched.A jagged and stretched break was identified on the proximal balloon glue joint, indicating excessive force applied to retract the catheter.The balloon material was bunched and slightly prolapsed over the distal tip.The balloon was stripped of its fibers and a circumferential rupture was found on the proximal cone of the balloon.The glue bullet was found lodged within the outer catheter, as the glue bullet was improperly formed and not perpendicular to the polyimide surface.It is possible that the glue bullet becoming lodged within the catheter and the balloon rupture contributed to the retraction issues.However, the definitive root cause could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.Operator awareness training regarding the glue bullet process was performed.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.Do not exceed the rbp recommended for this device.Balloon rupture may occur if the rbp rating is exceeded.To prevent over pressurization, use of a pressure monitoring device is recommended.Additionally, specific directions for the use of the conquest pta dilatation catheter are included in the ifu.

Manufacturer Narrative

The investigation is confirmed for a product quality issue, as the glue bullet was found to be improperly formed.

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 facility 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 facility was able to provide new patient information, which was updated in the appropriate sections.

• 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: 3830202
• MDR Text Key: 4502893
• Report Number: 2020394-2014-00213
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2014

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: 12/31/2016
• Device Catalogue Number: CQ7588
• Device Lot Number: REXK2242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/16/2014
• Initial Date FDA Received: 05/12/2014
• Supplement Dates Manufacturer Received: 07/16/2014
• Supplement Dates FDA Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female