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); Retraction Problem (1536)

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

Event Date 07/05/2015

Event Type  Injury  

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.

Event Description

It was reported that after the initial inflation, a pta balloon would not deflate.The health care provider reported a needle stick through the skin was used to aspirate the contrast out of the balloon, and successfully deflate it.There was no known impact or consequence 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.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 12mm x 4cm balloon.The distal end of the balloon was protruding from the distal end of the sheath.The distal tip of the introducer sheath was observed to be flared, indicating retraction issues.Additionally, the proximal end of the sheath was bunched.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 unable to be retracted from the introducer sheath.The balloon was able to advance through the introducer sheath.An attempt was made to inflate the balloon with water using an in-house inflation device.The balloon was unable to be inflated, as water leaked through the balloon fibers 4.7cm from the distal tip.The balloon was stripped and the location of the reported needle stick was found 4.8cm from the distal tip.The balloon was cut at the proximal cone to examine the inflation/deflation port in an attempt to determine why the balloon would not deflate.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.Medical records/image/photo review: no medical records or medical images have been made available to the manufacturer.Conclusion: the device was returned within a 7fr introducer sheath.The investigation is inconclusive for deflation issues, as the balloon was unable to be functionally tested 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, causing the glue bullet to become lodged within the outer catheter shaft.The investigation is also confirmed for retraction problems, as the balloon was unable to be retracted through the sheath.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 0.0628", the glue bullet measured to be 0.0576".The root cause for the glue bullet becoming lodged in the catheter shaft is manufacturing related and likely caused the deflation issues, which lead to the retraction 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 BALLOON 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: 4990545
• MDR Text Key: 22738532
• Report Number: 2020394-2015-01286
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K083657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 07/05/2015

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: 06/30/2017
• Device Catalogue Number: CQ75124
• Device Lot Number: REYFR0481
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/17/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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