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

Catalog Number CQ7584

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

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

Event Date 07/24/2023

Event Type  malfunction  

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 was noted at the distal end of 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 performed.Unraveled fibers was noted at the distal end of balloon during the visual evaluation of the returned sample and during the microscopic observation, a longitudinal balloon rupture was noted.Therefore, the investigation was confirmed for the identified unraveled fiber and also confirmed for the reported balloon rupture.A definitive root cause for the reported balloon rupture 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: 01/2026).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.

Event Description

It was reported that during an angioplasty procedure for upper arm treatment, the pta balloon allegedly burst at 12 atm.There was no reported patient injury.

• 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: 18054497
• MDR Text Key: 327141705
• Report Number: 2020394-2023-00973
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741063114
• UDI-Public: (01)00801741063114
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 10/27/2023

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: CQ7584
• Device Lot Number: REHP2377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/02/2023
• 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