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

Model Number CQ5064

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided for the malfunction, therefore, a lot history review could be performed.The device was returned to the manufacturer for evaluation.The evaluation of the reported malfunction identified a longitudinal rupture and peeled pebax.The root cause is unknown.The device is labeled for single use.The catalog number identified has not been cleared in the us, but is similar to the conquest products that are cleared in the us.The pro code for the conquest product is identified.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model cq5064j pta dilatation catheter allegedly experienced longitudinal balloon rupture.This information was received from one source.This malfunction involved a patient with no consequences.Age, weight, and gender of the patient was not provided.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model cq5064j pta dilatation catheter allegedly experienced longitudinal balloon rupture.This information was received from one source.This malfunction involved a patient with no consequences.Age, weight, and gender of the patient was not provided.

Manufacturer Narrative

H10: as the lot number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation and two electronica photos were provided and reviewed.Therefore, the investigation is confirmed for the reported balloon rupture.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the conquest products that are cleared in the us.The pro code for the conquest product is identified in d2.H11: section a through f - the information provided by bd represents all of 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.

• Brand Name: CONQUEST PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10276611
• MDR Text Key: 198910455
• Report Number: 2020394-2020-04461
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741062872
• UDI-Public: (01)00801741062872
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CQ5064
• Device Catalogue Number: CQ5064J
• Device Lot Number: REDY3902
• Date Manufacturer Received: 09/30/2020
• Patient Sequence Number: 1