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

Model Number	DR80610
Medical Device Problem Codes	Break (1069); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device for this malfunction has been returned to the manufacturer for evaluation.The investigation of the reported malfunction is currently underway.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model dr80610 pta balloon dilatation catheter allegedly experienced break and puncture.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient¿s age, weight, and sex were not provided.
Additional Manufacturer Narrative
H10: a lot number was provided and a lot history review was performed.The device for this malfunction has been returned to the manufacturer for evaluation and confirmed for a break.A root cause could not be determined.The device is labeled for single use.H10: g4.H11: b5, h6(device code, results, conclusion).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 model dr80610 pta balloon dilatation catheter allegedly experienced break.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient¿s age, weight, and sex 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: 9597124
• Report Number: 2020394-2020-00515
• Device Sequence Number: 2423469
• Product Code: DQY
• UDI-Device Identifier: 00801741058837
• UDI-Public: (01)00801741058837
• 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): 04/03/2020

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: DR80610
• Device Catalogue Number: DR80610
• Device Lot Number: 93ND0148
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 04/03/2020
• Patient Sequence Number: 1