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 Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/20/2015

Event Type  malfunction  

Event Description

It was reported that during the first inflation the pta balloon would not inflate in an av fistula.There was no reported retraction difficulty through the sheath.Another balloon was used to complete the procedure.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.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.

Manufacturer Narrative

The lot number was provided and the lot device history records were reviewed.The lot met all release criteria.This is the only complaint reported for this lot number and issue to date.Visual inspection: the balloon was returned in its original folded configuration.No other anomalies were noted to the device.Functional/performance evaluation: the patency of the guidewire lumen was tested and passed without issue.The inflation hub was connected to an inflation device and an attempt was made to inflate the balloon with water.The balloon did not inflate.The balloon was cut at the proximal cone to examine the inflation/deflation lumen.After opening the balloon, it was noted that the glue bullet was lodged in the outer catheter shaft and was blocking the inflation/deflation ports.The glue bullet was removed from the outer catheter shaft and was found to be damaged.The od of the glue bullet could not be measured due to the damage.The polyimide was also kinked just distal to the glue bullet, possibly indicating that the catheter was subjected to excessive force.Medical records & image/photo review: no medical records or images/photos were provided for review.Conclusion: 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 glue bullet was found to be damaged and the polyimide just distal to the glue bullet was kinked, indicating that the catheter was likely subjected to excessive force.The root cause for the glue bullet becoming damaged is unknown.The root cause for the inflation issues is likely related to the damaged glue bullet becoming lodged within the catheter shaft.Labeling review: 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.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: 4905401
• MDR Text Key: 6836956
• Report Number: 2020394-2015-01000
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2015

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: 10/31/2017
• Device Catalogue Number: CQ7584
• Device Lot Number: REYK0909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 07/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2014
• 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 Age: 68 YR