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

Catalog Number CQ75124

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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 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.

Event Description

It was reported that the balloon did not fully deflate after one inflation at 18 atm pressure during a basilic vein angioplasty.The balloon and sheath were retracted together as there was allegedly difficulty retracting thru the sheath.No patient injury was reported.

Manufacturer Narrative

(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.

Manufacturer Narrative

A manufacturing review was performed.The lot met all release criteria.This is the only complaint reported for this lot number and issue to date.Visual/functional inspection: the distal end of the balloon was protruding from the distal end of the sheath.The catheter was stretched and bunched throughout its length.The distal tip of the introducer sheath was observed to be flared.The patency of the guidewire lumen was tested and it passed.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, but the balloon was unable to be inflated.The balloon was stripped and 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.The glue bullet was examined under a microscope and the edge of the bullet was not perpendicular to the polyimide.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 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 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 current ifu (instructions for use) states: when the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated.If resistance is met during manipulation, determine the cause of the resistance before proceeding.Applying excessive force to the catheter can result in tip breakage or balloon separation.While maintaining negative pressure and the position of the guidewire, withdraw the deflated dilatation catheter over the wire through the introducer sheath.Use of a gentle counterclockwise motion may be used to help facilitate catheter removal through the introducer sheath.

• Brand Name: CONQUEST PTA DILIATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; parque industrial colonial; 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: 5016288
• MDR Text Key: 23816223
• Report Number: 2020394-2015-01336
• 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
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 07/22/2015

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: 08/31/2017
• Device Catalogue Number: CQ75124
• Device Lot Number: REYH1366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/14/2015; 11/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2014
• 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 Age: 62 YR
• Patient Weight: 63