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

Catalog Number CQ75124

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 06/02/2015

Event Type  malfunction  

Event Description

It was reported that the pta balloon was slow deflate.The balloon was inflated and deflated multiple times to fully deflate it.There was no reported retraction difficulty through the sheath.There was no reported pt 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 mfr for eval.The investigation is currently underway.The info provided by bard represents all of the known info at this time.Despite good faith efforts to obtain additional info, the complainant/ reporter was unable or unwilling to provide any further pt, product, or procedural details to bard.

Manufacturer Narrative

Manufacturing review: the lot number was provided and the lot device history records were reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Visual inspection: the device was returned.The balloon appeared to have been previously inflated.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 the balloon was inflated with water to rated burst pressure (rbp) of 20 atm.Several attempts were made to deflate the balloon, but were unsuccessful.The balloon was cut near the inflation/deflation ports and it was noted that the glue bullet was not in its correct location and was lodged inside the outer catheter shaft, blocking the inflation/deflation ports.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 and the flat edge was slanted, causing it to become lodged inside the outer catheter shaft.Medical records & image/photo review: no medical records or images/photos were provided for review.Conclusion: the investigation is confirmed for deflation issues, as the balloon was unable to be deflated under laboratory conditions.The investigation is confirmed for a product quality issue, as the 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.Additionally, the flat edge of the glue bullet was slanted and was not perpendicular to the polyimide.The root cause for the glue bullet becoming lodged in the catheter shaft is manufacturing related and caused the deflation issues.Labeling review: specific warnings, precautions and directions for use of the conquest pta dilatation catheter are included in the current instructions for use (ifu).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.; 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: 4905373
• MDR Text Key: 6020071
• Report Number: 2020394-2015-00993
• 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: 06/03/2015

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: 02/28/2018
• Device Catalogue Number: CQ75124
• Device Lot Number: REZC0616
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/24/2015
• 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: 11/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2015
• 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: 54 YR