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

Catalog Number CQ7584

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 Date 06/08/2015

Event Type  malfunction  

Event Description

It was reported that the pta balloon would not fully deflate and then could not be retracted through the introducer sheath.The catheter and sheath were removed together as a single unit without further incident.Another balloon was used to complete the procedure.There was no reported patient injury.

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.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 to any further patient, product, or procedural details to bard.

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.Visual inspection: the sample was returned.The distal end of the balloon was protruding from the distal end of the 7fr sheath.The catheter was stretched and bunched throughout its length, likely indicating retraction issues.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.The balloon was unable to be retracted from the introducer sheath; however, it could be advanced through the sheath.An attempt was made to inflated the balloon with water using an inflation device; however, the balloon would not inflate.The balloon was stripped and cut at the proximal cone to examine the inflation/deflation port and it was identified 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 diameter of the glue bullet was too small, causing it to become lodged inside the outer catheter shaft.Dimensional evaluation: per specifications, the acceptable range for the glue bullet od is 0.0600 +/- 0.0010¿.The od of the glue bullet was measured, and found to be 0.0580".This measurement was not within the acceptable range.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: 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 od did not meet the minimum required specification of 0.0590, causing the glue bullet to become lodged within the outer catheter shaft.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 pta balloon dilatation catheter 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 BALOON 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: 4906439
• MDR Text Key: 15914427
• Report Number: 2020394-2015-01013
• 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,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2015

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: CQ7584
• Device Lot Number: REZC0272
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/18/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2015
• Initial Date FDA Received: 07/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2015
• 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