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

Model Number DR80610

Device Problems Inflation Problem (1310); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review was performed.The sample was not returned to the manufacturer for evaluation.Therefore, the investigation of the reported event is inconclusive for inflation problem, balloon detachment and difficult to remove.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.

Event Description

This report summarizes three malfunction.A review of the reported information indicated that model dr80610 pta dilatation catheter allegedly experienced inflation problems, balloon detachment and was difficult to remove.The malfunction had no patient contact.

Manufacturer Narrative

H10: as the lot number for the device was provided, a manufacturing review was performed.The sample was not returned to the manufacturer for evaluation.Therefore, the investigation of the reported event is inconclusive for inflation problem, balloon detachment and difficult to remove.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H11: b5.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.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model dr80610 pta dilatation catheter allegedly experienced inflation problems, balloon detachment and was difficult to remove.There was no reported patient contact.

• Brand Name: DORADO 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: 10286774
• MDR Text Key: 199246875
• Report Number: 2020394-2020-04543
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741058837
• UDI-Public: (01)00801741058837
• 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: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DR80610
• Device Catalogue Number: DR80610
• Device Lot Number: 93VD0062
• Date Manufacturer Received: 06/30/2020
• Patient Sequence Number: 1