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

Catalog Number CQ5074

Device Problems Peeled/Delaminated (1454); Material Rupture (1546); Unraveled Material (1664)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2023

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure, the pta balloon catheter tip was allegedly ruptured at 20 atm.It was further reported that the balloon was removed from the sheath.The procedure was completed by using another device.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one conquest pta dilatation catheter was returned for evaluation.Unraveled fibers and peeled pebax were noted at the proximal end of the balloon.No specific anomalies were noted on the returned device during the visual evaluation.On functional testing, the balloon was inflated with an in-house presto inflation device.Water was leaking from the balloon; further, the balloon was stripped, and under microscopic observations, a longitudinal rupture was noted in the balloon.No other functional testing was done.One photo was reviewed.The photo was of the balloon catheter coiled within a plastic bag and the balloon appeared in deflated condition.No other specific anomalies and no objective evidence of balloon rupture are noted in the submitted photo.However, during sample analysis of the returned device, unraveled fibers and peeled pebax were noted at the distal end of the balloon during the visual evaluation and during the microscopic observation, a longitudinal balloon rupture was noted.Therefore, the investigation is confirmed for the reported balloon rupture and also confirmed for the identified unraveled fibers and peeled pebax.A definitive root cause for the reported balloon rupture, identified unraveled fibers and peeled pebax could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 01/2025) h11: section a through f ¿ the information provided by bd represents all 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 bd.H3 other text : see h10.

• Brand Name: CONQUEST
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18036950
• MDR Text Key: 326925640
• Report Number: 2020394-2023-00942
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741062957
• UDI-Public: (01)00801741062957
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K083657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CQ5074
• Device Lot Number: REGP2203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• 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