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

Model Number CQ75124

Device Problems Material Frayed (1262); Peeled/Delaminated (1454); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

No medical records were provided to the manufacturer.Images were provided.The lot number for the device was not provided.The images are currently under review.The device was returned to the manufacturer for evaluation.The investigation is currently under way.

Event Description

It was reported that during post procedure and upon removal from the introducer sheath, the pta balloon fibers were allegedly found to be unraveled.The procedure was completed upon removal of the pta balloon, with no further treatment provided.There was no reported patient injury.

Manufacturer Narrative

A complete manufacturing review could not be conducted as the investigation is lot number unknown.The device was returned for evaluation.A visual inspection found the outer layer to be peeled from the balloon and fibers to be disturbed on the distal cone.There was also unraveling of the fibers with outer layer wrapped around the strand.When inflating the balloon, the distal cone of the balloon took an asymmetrical shape due to a fiber disturbance.Therefore, the investigation is confirmed for peeled outer layer, fiber disturbance, unraveling, and deformation of the balloon during inflation.The constricted fibers at the distal cone of the balloon caused the balloon to take the asymmetric shape upon inflation.However, the definitive root cause for the identified fiber constriction or peeled outer layer 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.

Event Description

It was reported that during post procedure and upon removal from the introducer sheath, the pta balloon fibers were allegedly found to be unraveled.The procedure was completed upon removal of the pta balloon, with no further treatment provided.There was no reported patient injury.

• Brand Name: CONQUEST PTA BALLOON DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 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 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7612336
• MDR Text Key: 111450945
• Report Number: 2020394-2018-00911
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741063251
• UDI-Public: (01)00801741063251
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 53 YR
• Patient Weight: 69