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); Difficult to Remove (1528); Retraction Problem (1536)

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

Event Type  malfunction  

Manufacturer Narrative

The device has been returned to the manufacturer for evaluation.No medical records or no 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 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 that the pta balloon catheter was allegedly difficult to deflate.It was further reported that the balloon catheter was allegedly difficult to remove through the sheath; therefore, the catheter and sheath were removed together as a single unit.There was no reported impact or consequence to the patient.

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 within a 7 fr sheath.The distal end of the balloon was examined under microscopic magnification and was observed to be slightly bulged and protruding out the distal end of the introducer sheath.No other anomalies were noted to the device at this time.The introducer sheath examined under microscopic magnification.The introducer sheath was bunched and the distal tip of the introducer sheath was observed to be flared, indicating retraction issues.Functional/performance evaluation: the patency of the guidewire lumen was tested using an 0.035¿ guidewire and it passed without issue.The balloon was unable to be retracted through the introducer sheath.The balloon was able to be advanced forward through the introducer sheath with slight resistance.The inflation hub was connected to an inflation device and an attempt to inflate the balloon with water was made.The balloon was unable to be inflated, as water leaked out of the fibers of the balloon 3.7cm from the distal tip.The balloon was able to be deflated and retracted through the sheath without issue.The balloon fibers were then stripped and the location of the pinhole leak was found 1.9cm from the distal tip.The pinhole found in the balloon is likely a result of the reported needle puncture to deflate the balloon.The balloon was cut with a scalpel near the inflation deflation ports.After removing the balloon material, 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 glue bullet did not have a flat edge.The stepped portion of the shaft was examined under microscopic magnification and was observed to be slightly oval in shape.Medical records & image/photo review: no medical records or images/photos were provided for review.Conclusion: the investigation is inconclusive for deflation issues, as the balloon was unable to be functionally tested due to the poor sample condition (i.E.Needle stick).The investigation is confirmed for a product quality issue, as the flat edge of the glue bullet was slanted.The investigation is also confirmed for retraction problems based on the condition of the returned samples (i.E.Catheter stretched and balloon bunched).The root cause for the deflation issues is unknown.It is unknown whether the deflation issues contributed to the retraction issues, as the user used a smaller sheath size than indicated per device labeling (7fr instead of 8fr).The flat edge of the glue bullet was slanted and not perpendicular to the polyimide.As the catheter was stretched and the stepped portion of the catheter shaft was damaged, it is possible that excessive force was exerted on the catheter and damaged the shaft, causing the glue bullet to become lodged.Labeling review: specific warnings, precautions and directions for use of the dorado pta dilatation catheter are included in the current instructions for use (ifu).(b)(4).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
• 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: 5447866
• MDR Text Key: 39022776
• Report Number: 2020394-2016-00184
• 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: 01/20/2016

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2016
• Initial Date FDA Received: 02/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2016
• 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