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

Model Number	DR80710
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported malfunction, a lot number was provided, and a lot history review was performed.The sample was returned for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the malfunction indicated that model dr80710 pta balloon dilatation catheter allegedly experienced a break and a leak.This report was received from one source.This malfunction involved a patient with no patient consequences.Age, weight, and gender were not provided for this patient.
Additional Manufacturer Narrative
H10: of the reported malfunction, was reassessed for reportability and determined to be no longer reportable.H10: for the reported malfunction, a lot number was provided, and a lot history review was performed.The sample was returned for evaluation.The investigation is unconfirmed for break, and inconclusive for the reported device leak.A root cause has not been determined.The device is labeled for single use.H10: g4 h11: h6 (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 (1) malfunction.A review of the malfunction indicated that model dr80710 pta balloon dilatation catheter allegedly experienced a break and a leak.This report was received from one source.This malfunction involved a patient with no patient consequences.Age, weight, and gender were not provided for this patient.

• 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: 9597317
• Report Number: 2020394-2020-00519
• Device Sequence Number: 19416980
• Product Code: DQY
• UDI-Device Identifier: 00801741059094
• UDI-Public: (01)00801741059094
• 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: DR80710
• Device Catalogue Number: DR80710
• Device Lot Number: 93XB0101
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 04/03/2020
• Patient Sequence Number: 1