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

Catalog Number CQ7564

Device Problems Material Frayed (1262); Material Rupture (1546); Material Deformation (2976)

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

Event Date 10/08/2023

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure, the balloon was filled with saline to dilate the stenosis near the patient's anastomosis and the pressure reached 30atm.After the second time, it broke and was safely recovered without causing damage to the patient's blood vessels.It was further reported that the middle part of the balloon was ruptured.The operation was completed by changing the new 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 balloon catheter was returned for evaluation.Frayed fibers and deformation at balloon material were noted at the distal end of the balloon; no other specific anomalies were noted during the visual evaluation.During the functional testing, the balloon was inflated with an in-house presto inflation device, and during the inflation, water was noted to be streaming from the balloon.Further, the balloon was stripped, and under microscopic observation, a longitudinal rupture was noted on the balloon.No other functional testing was performed.Frayed fiber and material deformation was also noted on the returned balloon during the visual evaluation and longitudinal balloon rupture was observed under microscopic observation.Therefore, the investigation was confirmed for the reported balloon rupture and identified frayed fiber and material deformation of balloon material.A definitive root cause for the reported balloon rupture and identified frayed fiber and material deformation of balloon material 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: 08/2025) 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: 18472632
• MDR Text Key: 333016143
• Report Number: 2020394-2024-00004
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741062902
• UDI-Public: (01)00801741062902
• 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: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CQ7564
• Device Lot Number: REGW1077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• 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