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

Catalog Number CQ75124

Device Problems Inflation Problem (1310); Product Quality Problem (1506)

Patient Problem No Patient Involvement (2645)

Event Date 05/28/2015

Event Type  malfunction  

Event Description

It was reported that the pta balloon catheter would not inflate.There was no reported pt involvement.

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

Manufacturing review: 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 inspection: the sample was returned.No visual anomalies were identified on the device.Functional/performance evaluation: the patency of the guidewire lumen was tested using an in-house 0.035" guidewire and it passed.The inflation hub was connected to an inflation device and an attempt was made to inflate the balloon with water.The balloon was not able to inflate.The balloon was cut at the proximal cone to examine the inflation/deflation lumen.After opening the balloon, it was identified that the glue bullet was lodged in the outer catheter shaft and was blocking the inflation/deflation ports.The flat edge of the bullet was noted to be slanted and was not perpendicular to the polyimide surface.The inflation/deflation ports were oval in appearance, indicating that the catheter may have been subjected to excessive force.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: no medical images have been made available to the manufacturer.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 investigation is confirmed for a product quality issue, as the flat edge of the glue bullet was slanted.The root cause for the glue bullet becoming lodged in the catheter shaft is manufacturing related and likely caused the deflation issues.It is possible that the catheter was also subjected to excessive force; as the inflation/deflation ports were oval in appearance.Labeling review: the current ifu (instructions for use) states: 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.Additionally, specific warnings, precautions, and potential complications associated with the device are included in the 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: 4898656
• MDR Text Key: 6537960
• Report Number: 2020394-2015-00973
• 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: 06/02/2015

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: 06/05/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2015
• Initial Date FDA Received: 06/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2016
• 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