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

Model Number	DR4054
Medical Device Problem Codes	Break (1069); Material Frayed (1262); Peeled/Delaminated (1454); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided, therefore a lot history review was performed.The device was returned for evaluation an the investigation is confirmed for the rupture and frayed issues.The definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model dr4054 pta balloon dilatation catheter allegedly experienced break, frayed, and rupture.The information was received from a single source.One patient was involved with no reported patient consequences.The patient's age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number was provided for the reported malfunction, therefore a lot history review was performed.The device was returned for evaluation.The investigation is confirmed for the balloon material fraying, break and catheter leak.However, the investigation is unconfirmed for the reported balloon rupture.The definitive root cause is unknown.The device is labeled for single use.H10: g4,h6(device: 1354).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 indicates that model dr4054 pta balloon dilatation catheter allegedly experienced break, leak, peeled or delaminated and rupture.The information was received from a single source.One patient was involved with no reported patient consequences.The patient's age, weight, and gender were not provided.

• 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: 10763802
• Report Number: 2020394-2020-06373
• Device Sequence Number: 1128533
• Product Code: DQY
• UDI-Device Identifier: 00801741058486
• UDI-Public: (01)00801741058486
• 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): 01/07/2021

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: DR4054
• Device Catalogue Number: DR4054
• Device Lot Number: 93ZD0040
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 01/07/2021
• Patient Sequence Number: 1