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

Model Number	DR4064
Medical Device Problem Codes	Break (1069); Leak/Splash (1354); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot no for the device was provided, therefore a lot history review was performed.The device was returned for evaluation.Therefore the investigation remains confirmed for all the reported failures saline leak, circumferential break and peeled pebax.Based upon the available information, the definitive root cause for this event is unknown.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 dr4064 pta balloon dilatation catheter allegedly experienced saline leak, circumferential break and peeled pebax.This report was received from one source.The (b)(6) year old female patient was (b)(6) kgs.There was no reported patient injury.

• 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: 10752893
• Report Number: 2020394-2020-06242
• Device Sequence Number: 11044328
• Product Code: DQY
• UDI-Device Identifier: 00801741058714
• UDI-Public: (01)00801741058714
• 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): 10/28/2020

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: DR4064
• Device Catalogue Number: DR4064
• Device Lot Number: 93ZD0053
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/28/2020
• Patient Sequence Number: 1