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

Catalog Number CQ5064J

Device Problems Material Rupture (1546); Unraveled Material (1664)

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

Event Date 10/27/2022

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured at 29 atm.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified in has not been cleared in the us but is similar to the conquest pta balloon dilatation catheter products that are cleared in the us.The pro code and 510 k number for the conquest pta balloon dilatation catheter products are identified.H10: 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: one conquest dilatation catheter was returned for evaluation.Unraveling fibers were able to be observed on the returned balloon catheter.There were no other specific anomalies noted during the visual evaluation.During functional testing, the balloon was inflated with the in-house inflation device, and water was noted to be leaking from the distal end.The balloon fibers were stripped, and a longitudinal rupture was observed.No other functional testing was performed.All the anomalies are noted by microscopic observation.Therefore, the investigation is confirmed for the reported balloon rupture, as a longitudinal rupture was noted on the balloon during functional testing of the returned device.The investigation is also confirmed for the identified unraveling of fiber, as the returned balloon was able to be observed with these anomalies during visual evaluation.A definitive root cause for the reported balloon rupture and identified unraveling of fiber could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling.Inadequacy.Expiry date: 01/2025.

• Brand Name: CONQUEST
• 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. -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: 16129163
• MDR Text Key: 308643268
• Report Number: 2020394-2022-01057
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741127182
• UDI-Public: (01)00801741127182
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/15/2022

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 Catalogue Number: CQ5064J
• Device Lot Number: REGP2669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2022
• 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