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

Model Number CQF75124

Device Problems Material Frayed (1262); Retraction Problem (1536); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2018

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.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 of an innominate vein with access gained through the subclavian vein, the balloon allegedly obtained a circumferential rupture.Resistance was felt while removing the device out of the sheath.The procedure was completed with another device.There was no reported patient injury.

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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation.A visual inspection found the outer layer peeled and fiber disturbance on the distal cone of the balloon.An attempt to inflated the device led to identifying both a complete circumferential rupture with a longitudinal rupture extending towards the distal tip.Therefore, the investigation is confirmed for the outer layer peeling, and fiber disturbance as well as for a compound rupture.However, the investigation is inconclusive for the reported retraction issue, as the device was unable to be fully functionally tested due to the returned sample condition.Per the reported event details, the user attempted to use a 7f merit introducer sheath for the procedure.The current instructions for use (ifu) states, "the minimal acceptable sheath french size is printed on the package label.Do not attempt to pass the pta catheter through a smaller size sheath introducer than indicated on the label." this device is labeled for use in a 8f sheath.It is possible that the compound rupture contributed to the identified outer layer of the balloon peeling and fiber issues.However, the definitive root cause for the identified issues could not be determined based on the available information.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.(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 of an innominate vein with access gained through the subclavian vein, the balloon allegedly obtained a circumferential rupture.Resistance was felt while removing the device out of the sheath.The procedure was completed with another device.There was no reported patient injury.

• 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: 7545638
• MDR Text Key: 109314996
• Report Number: 2020394-2018-00730
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741060663
• UDI-Public: (01)00801741060663
• 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: 08/15/2018

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: 02/28/2021
• Device Model Number: CQF75124
• Device Catalogue Number: CQF75124
• Device Lot Number: RECP0193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Initial Date Manufacturer Received: 04/30/2018
• Initial Date FDA Received: 05/25/2018
• Supplement Dates Manufacturer Received: 07/31/2018
• Supplement Dates FDA Received: 08/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 91 YR