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

Model Number DR13572

Device Problems Break (1069); Deflation Problem (1149); Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device was provided, a manufacturing review was performed.The device was returned to bd and is pending evaluation.The company is still investigating the issue at this time.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that the model dr13572 pta dilatation catheter allegedly failed to inflate and deflate.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient's age, sex and weight were not reported.

Manufacturer Narrative

H10: the lot number for the device was provided, and a lot history review was performed.The device was returned to the manufacturer for inspection/evaluation.The investigation is confirmed for inflation problem and break; however, the investigation is inconclusive for deflation problem.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.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 the model dr13572 pta dilatation catheter allegedly failed to inflate and deflate.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient's age, sex and weight were not reported.

• 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: 10286691
• MDR Text Key: 199245321
• Report Number: 2020394-2020-04530
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741058936
• UDI-Public: (01)00801741058936
• 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: 10/13/2020

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: No Information
• Device Model Number: DR13572
• Device Catalogue Number: DR13572
• Device Lot Number: 93XD0110
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 10/13/2020
• Patient Sequence Number: 1