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

Catalog Number CQ5064J

Device Problems Break (1069); Material Frayed (1262); Peeled/Delaminated (1454); Material Rupture (1546)

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

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

H10: the catalog number identified in section d4 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 in d2 and g4.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.During visual analysis, peeled peebax and fiber disturbance were noted to the proximal end of the balloon.Also, material frayed, and fiber disturbance were noted to the distal end of the balloon.No other specific anomalies were noted.On functional testing, an in-house presto inflation device was used to inflate the balloon and water was noted to be streaming from the distal end of the catheter shaft.Further, the balloon fibers where stripped and under microscopic examination a partial circumferential break was noted to the guidewire lumen from the distal tip.However, no evidence of balloon rupture could be identified on the returned device.No other functional testing was performed.Based on the visual analysis of the returned sample, peeled peebax, fiber disturbance and material frayed at the proximal and distal end of balloon were noted, so the investigation is confirmed for the identified peeled material, fiber disturbance and material frayed issue.Further, on the microscopic observation, a circumferential break in the guidewire lumen was also noted which could have been the source of the leak from the distal tip during inflation; hence, the investigation is confirmed for the identified inner guidewire lumen break.However, in the sample analysis, a significant evidence of balloon rupture could not be identified so, the investigation remains inconclusive for reported balloon rupture.A definitive root cause for the reported balloon rupture and identified peel peebax, material frayed, fiber disturbance, inner guidewire lumen break 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: 05/2026) 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, the pta balloon allegedly ruptured at 20 atm.The procedure was completed using another device.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: 18874512
• MDR Text Key: 337317287
• Report Number: 2020394-2024-00331
• 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: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• 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: REHT3660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• 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