MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA DILATATION CATHETER; 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); No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2015

Event Type  Injury  

Event Description

It was reported that after post dilating a stent in the iliac artery, the balloon would not deflate.The health care provider reported that a coronary artery needle was advanced percutaneously through the skin to puncture and deflate the balloon.The hcp further reported the remainder of the casework was rescheduled for a later date.There was no impact or consequence to the patient.

Manufacturer Narrative

No hospital//medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard represents all of the 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 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.Visual/microscopic inspection: the balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as an 10mm x 4cm balloon.Slight bunching of the balloon material was noted near the distal tip, possibly indicating that the glue bullet had become lodged inside the outer catheter.The user reported that there were no difficulties retracting the balloon through the sheath.Fiber disturbance was noted approximately 2.1cm from the distal tip, possibly due to the user puncturing the balloon with the needle.No other anomalies were noted to the device at this time.Functional/performance evaluation: the patency of the guidewire lumen was tested using an in-house 0.035¿ guidewire, and it passed without issue.The inflation hub was connected to an inflation device and an attempt was made to inflate the balloon with water.Attempts were made to inflate and deflate the balloon with water.The balloon was unable to be inflated.No fiber disturbances were noted to the balloon.The balloon was cut with a scalpel near 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.The polyimide was pulled distally to remove the glue bullet from the outer catheter.Upon removal, it appeared that the diameter of the glue bullet was too small, causing it to become lodged inside the outer catheter shaft.Additionally, the flat edge of the glue bullet was slanted.Medical records review: no medical records have been made available to the manufacturer.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the device was returned.The investigation is inconclusive for deflation issues, as the balloon was unable to be inflated due to the glue bullet blocking the inflation/deflation port.The investigation is confirmed for a product quality issue, as the outer diameter (od) of the glue bullet was too small and the flat edge was slanted, causing the glue bullet to become lodged within the outer catheter shaft.The evaluation found the glue bullet was lodged within the catheter shaft, blocking the inflation/deflation ports.The od of the glue bullet was too small and did not meet the minimum required specification of 0.0618", the glue bullet measured 0.0592".Additionally, the flat edge of the glue bullet was slanted and not perpendicular to the polyimide.The root cause for the glue bullet becoming lodged in the catheter shaft is manufacturing related and likely caused the inflation/deflation issues.Labeling review: 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.

• Brand Name: CONQUEST PTA DILATATION CATHETER
• Type of Device: 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: 4947112
• MDR Text Key: 19738798
• Report Number: 2020394-2015-01244
• 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,hea
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/25/2015

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: 09/30/2017
• Device Catalogue Number: CQ75104
• Device Lot Number: REYJ0222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/25/2015
• Initial Date FDA Received: 07/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 93