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

Catalog Number CQ75104

Device Problems Deflation Problem (1149); Product Quality Problem (1506)

Patient Problems No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)

Event Date 04/23/2015

Event Type  Injury  

Event Description

It was reported that the balloon did not deflate during the angioplasty.A needle stick through the skin was used to deflate the balloon.No pt injury reported.

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 mfr for eval.The investigation is currently underway.

Manufacturer Narrative

A manufacturing review was conducted.The lot met all release criteria.Visual/functional inspection.The sample was returned bloody.The balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 10mm x 4cm balloon.The balloon appeared to have been previously inflated.A complete catheter detachment was noted 22.5cm from the distal tip.This will be considered an incidental finding, as it was not reported by the user.The balloon was unable to be inflated due to the catheter detachment.The balloon was cut at the proximal cone to examine the inflation/deflation ports.Upon removing the balloon, it was noted that the glue bullet was not in its correct location and was lodged inside the outer catheter shaft.Additionally, the site of the reported needle stick was located 1.5cm from the distal tip.The polyimide was pulled distally to remove the glue bullet from the outer catheter.Upon removal, it appeared that the flat edge of the glue bullet was not perpendicular to the polyimide shaft, causing it to become lodged inside the outer catheter shaft.Conclusion: the investigation is inconclusive for deflation issues, as the balloon was unable to be inflated due to it being returned in two segments.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 evaluation found the glue bullet was lodged within the catheter shaft, partially blocking the inflation/deflation ports.Additionally, the glue bullet did not appear perpendicular to the polyimide surface, which may have contributed to it becoming lodged.The root cause for the glue bullet becoming lodged in the catheter shaft is manufacturing related and likely caused the deflation issues.Labeling review: the current ifu (instructions for use) states: 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.Use of the conquest pta dilatation catheter: position the balloon relative to the lesion to be dilated, ensure the guidewire is in place and inflate the balloon to the appropriate pressure.Apply negative pressure to fully evacuate fluid from the balloon.Confirm that the balloon is fully deflated under fluoroscopy.

• 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: 4795820
• MDR Text Key: 5832186
• Report Number: 2020394-2015-00786
• 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: 04/24/2015

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: 10/31/2017
• Device Catalogue Number: CQ75104
• Device Lot Number: REYK0738
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/07/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2015
• Initial Date FDA Received: 05/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2014
• 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