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

Model Number	DR8088
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, lot number was provided, and a lot history review was performed.The sample was returned for evaluation.Break and leak were confirmed for the malfunction.A root cause has not been determined.The device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model dr8088 pta balloon dilatation catheter allegedly experienced leak/splash and break.This report was received from a single source.This malfunction involved a patient with no patient consequences.The patient is (b)(6) years of age, the gender is female, and the weight is (b)(6) kgs.

• 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: 9979591
• Report Number: 2020394-2020-03073
• Device Sequence Number: 2089504
• Product Code: DQY
• UDI-Device Identifier: 00801741059322
• UDI-Public: (01)00801741059322
• 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
• Report Date (Section B): 04/20/2020

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: DR8088
• Device Catalogue Number: DR8088
• Device Lot Number: 93SD0140
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/20/2020
• Patient Sequence Number: 1