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); Retraction Problem (1536)

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

Event Date 07/09/2015

Event Type  malfunction  

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 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.

Event Description

It was reported during an angioplasty procedure, a pta balloon would not fully deflate in the subclavian.The health care provider reported that device was difficult to retract through the sheath.The hcp further reported that the pta balloon was removed in its entirety, with the sheath, as a single system.The procedure was said to be complete after the device was removed.There was no reported consequence or impact to the patient.

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.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.The entire balloon was received fully inserted past the distal end of the introducer sheath.The distal balloon material was slightly bunched in appearance.The catheter was kinked 20.2cm from the distal tip.However after review of the preliminary pictures, the manner in which the device was packaged for return may have contributed to the kinks in the catheter and polyimide.No kinks were reported by the user.The distal tip of the introducer sheath was observed to be flared, indicating retraction issues.The proximal end of the sheath was slightly bunched in appearance.No other anomalies were observed to the sheath.Functional/performance evaluation: the patency of the guidewire lumen was tested using an in-house 0.035" guidewire and it passed without issue.The balloon was then able to be retracted through the sheath without issue.The balloon was inserted through an in-house 7fr sheath without issue.The balloon was inflated to rbp (24atm), and then deflated.The balloon took the appropriate shape upon inflation.The balloon was deflated without issue.The balloon was stripped and cut at the proximal cone to examine the inflation/deflation ports.After opening the balloon, no anomalies were noted to the inflation/deflation ports.The glue bullet was in the correct location and was not blocking the inflation/deflation ports.The edge of the glue bullet was slanted and was not perpendicular to the polyimide.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 confirmed for retraction issues as the balloon was returned within the customer's introducer sheath and the distal end of the introducer sheath was flared.The investigation is unconfirmed for deflation issues, as the balloon was able to be inflated and deflated without issue.The investigation is confirmed for a product quality issue, as the flat edge of the glue bullet was slanted.The root cause for the deflation issues is unknown, as the balloon was able to be inflated and deflated without issue during functional testing.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: the conquest pta instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.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 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: 5054612
• MDR Text Key: 25627892
• Report Number: 2020394-2015-01574
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/11/2015

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: 12/31/2017
• Device Catalogue Number: CQ75104
• Device Lot Number: REZA0111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2015
• Initial Date FDA Received: 09/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2015
• 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: 52 YR
• Patient Weight: 76