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 Problem Pain (1994)

Event Date 06/01/2015

Event Type  Injury  

Event Description

It was reported that the pta balloon would not deflate.Medical intervention (a needle stick through the skin) was necessary to deflate the balloon and remove the device.Patient experienced pain during retraction of the balloon catheter to the cephalic arch.

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 not 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 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.This is the only complaint reported for this lot number and issue to date.Visual inspection: the sample was returned.The distal end of the balloon was protruding out of the distal end of an 8fr introducer sheath.No other anomalies were observed to the device.The distal end of the sheath was examined.The edge of the sheath tip was noted to be flared out, which indicates retraction issues.The sheath was also bunched near the proximal hub.The retraction issues were likely a result of the balloon being unable to fully deflate.Functional/performance evaluation: an attempt was made to retract the catheter through the sheath; however, this was unsuccessful.The balloon was able to be advanced through the sheath with resistance.Upon removal, it was noted that the distal portion of the balloon was slightly bunched at the distal tip, likely indicating retraction issues.There was no fiber disturbance noted on the balloon.The patency of the guidewire lumen was tested using an in-house 0.035¿ guidewire, and it passed with no issues.The device was attached to an inflation device.Upon inflation, the balloon leaked from the proximal cone.The balloon was stripped and cut at the proximal cone and the site of the reported needle stick was noted 5.5cm from the distal tip.The glue bullet was not visible against the outer catheter shaft was blocking the inflation/deflation ports.The polyimide was pulled distally to reveal the glue bullet.The glue bullet did not appear to be large enough in diameter and the edge of the bullet was not perpendicular to the polyimide.Dimensional evaluation: per specification, the acceptable range for the glue bullet od is 0.0638 +/- 0.0010¿.The od of the glue bullet was measured, and found to be 0.0625".This measurement was not within the acceptable range.Medical record/image/photos review: no medical records, images or photos were 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 needle stick performed by the user.The investigation is confirmed for a product quality issue, as the od of the glue bullet did not meet the minimum required specification of 0.0628" and the flat edge was slanted, causing the glue bullet to become lodged within the outer catheter shaft.The investigation is also confirmed for retraction problems, as the balloon could not be retracted through the returned introducer sheath.The root cause for the glue bullet becoming lodged in the catheter shaft is manufacturing related and likely caused the deflation issues.An internal investigation is on-going to identify any applicable corrective and/or preventative actions.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.

• Brand Name: CONQUEST 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: 4895904
• MDR Text Key: 6069080
• Report Number: 2020394-2015-00977
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K083657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2015

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: 11/30/2017
• Device Catalogue Number: CQ75124
• Device Lot Number: REYL0682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/05/2015
• Initial Date FDA Received: 06/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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