MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number CQF75102

Device Problems Material Frayed (1262); Peeled/Delaminated (1454); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number of the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.(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.

Event Description

It was reported that during a pta procedure the balloon allegedly ruptured.There was no reported patient injury.

Event Description

It was reported that during a pta procedure the balloon allegedly ruptured.There was no reported patient injury.

Manufacturer Narrative

The device history records have been reviewed and this 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 to date for this lot number and failure mode.The device was returned for evaluation.A visual inspection found the device stuck in the user's introducer sheath.Stretching to the catheter shaft and damage to the introducer sheath were noted, and balloon material was seen folded over the distal tip of the device.Therefore, the investigation is confirmed for sheath related retraction issues.The sheath was able to be pulled back from the balloon, and frayed balloon fibers and peeled pebax were noted on the balloon material.Additionally, two longitudinal ruptures were noted to the balloon.Therefore, the investigation is confirmed for frayed fibers, peeled pebax, and for longitudinal ruptures.It is likely that the ruptures resulted in the identified retraction issues through the introducer sheath.However, the definitive root cause for the identified rupture and fiber and pebax issues could not be determined based on the available information.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

• Brand Name: CONQUEST 40 PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7593152
• MDR Text Key: 110851825
• Report Number: 2020394-2018-00848
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060625
• UDI-Public: (01)00801741060625
• Combination Product (y/n): N
• PMA/PMN Number: K120660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/16/2018

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: 09/30/2020
• Device Model Number: CQF75102
• Device Catalogue Number: CQF75102
• Device Lot Number: REBW2105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Initial Date Manufacturer Received: 05/16/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 08/07/2018
• Supplement Dates FDA Received: 08/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1