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

Catalog Number CQ75124

Device Problems Deflation Problem (1149); Inflation Problem (1310); Product Quality Problem (1506); Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2015

Event Type  Injury  

Event Description

It was reported that a pta balloon was difficult to inflate during use in the svc, however the balloon was still used for treatment.The health care provider reported the pta balloon then failed to deflate and could not be retracted through the 8fr sheath.The hcp further reported a needle stick through the skin was used to deflate the balloon.There was no known impact or consequence to the patient.

Manufacturer Narrative

No device, no medical records and no medical images have been made available to the manufacturer.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.Based on available information provided, the root cause could not be determined.It is unknown whether patient and/or procedural issues contributed to the event.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.

Manufacturer Narrative

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.

Manufacturer Narrative

Visual/microscopic inspection: the balloon was received fully advanced through the introducer sheath, with the balloon fully visible.The distal end of the balloon was examined under microscopic magnification and was observed to be slightly bunched.Fiber disturbance was noted approximately 5.8cm from the distal tip, likely due to the reported needle stick used to deflate the balloon.The catheter was kinked approximately 66.8cm from the distal tip.The balloon was also kinked on the barrel of the balloon.However after review of the preliminary pictures, the manner in which the device was packaged for return may have contributed to the kinks.No kinks were reported by the user.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 in-house 0.035¿ guidewire, and it passed without issue.The balloon was unable to be retracted through the introducer sheath.The inflation hub was connected to an inflation device and an attempt was made to inflate the balloon with water.The balloon was unable to be inflated, as water leaked out of the fibers of the balloon 5.8cm from the distal tip.The balloon fibers were then stripped and the site of the needle stick was found approximately 5.1cm from the distal tip.The balloon was cut with a scalpel near the inflation deflation ports.Upon removing the balloon, 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 flat edge of the glue bullet was slanted and not perpendicular to the polyimide.The stepped portion of the shaft was examined under microscopic magnification and was observed to be slightly oval in shape.Conclusion: the device was returned within a 7fr introducer sheath.The investigation is inconclusive for inflation and 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 sample (i.E.Introducer sheath tip flared).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); therefore, user-related issues may have contributed to the retraction issues.The flat edge of the glue bullet was slanted and not perpendicular to the polyimide.As 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.(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 DILIATION 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: 4961792
• MDR Text Key: 6190208
• Report Number: 2020394-2015-01261
• 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,Followup
• Report Date: 06/30/2015

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: 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?: No
• Initial Date Manufacturer Received: 06/30/2015
• Initial Date FDA Received: 07/30/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/04/2016; 04/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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 Outcome(s): Required Intervention