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

Model Number	DR13572
Medical Device Problem Codes	Break (1069); Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10286691
• Report Number: 2020394-2020-04530
• Device Sequence Number: 485716
• Product Code: DQY
• UDI-Device Identifier: 00801741058936
• UDI-Public: (01)00801741058936
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Model Number: DR13572
• Device Catalogue Number: DR13572
• Device Lot Number: 93XD0110
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 10/13/2020
• Patient Sequence Number: 1