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

Model Number CQ75124

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

Patient Problem No Patient Involvement (2645)

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

No hospital/medical records or 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 return of the device is pending.The investigation of the reported event is currently underway.(expiry date: 12/2020).

Event Description

It was reported that during preparation for an angioplasty procedure, the pta balloon was allegedly found to have frayed material.Another device was used to perform the procedure.There was no reported patient injury.

Event Description

It was reported that during preparation for an angioplasty procedure, the pta balloon was allegedly found to have frayed material.Another device was used to perform the procedure.There was no reported patient contact.

Manufacturer Narrative

Manufacturing review: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.Investigation summary:the device was returned for evaluation.A visual inspection found peeling pebax throughout the length of the balloon.However, no frayed or unraveling fibers were identified on the balloon.Therefore, the investigation is confirmed for peeling pebax, and is unconfirmed for the reported frayed material.It is likely that the user perceived the peeling pebax as frayed material.The definitive root cause for the identified peeling pebax could not be determined based upon the available information.An investigation is currently open to address the peeling pebax issue.Labeling review: 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 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: 8196991
• MDR Text Key: 131430099
• Report Number: 2020394-2018-02224
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741063251
• UDI-Public: (01)00801741063251
• Combination Product (y/n): N
• PMA/PMN Number: K083657
• 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: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CQ75124
• Device Catalogue Number: CQ75124
• Device Lot Number: RECN0247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1