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

Model Number	DR13564
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: one dorado pta dilatation catheter has returned for evaluation.On the visual evaluation of the device, it appeared bloody, no other specific anomalies noted.On the functional evaluation of the device, the guide wire lumen was flushed, and an in-house guide wire was inserted through the catheter without any issue, on further the device was inflated with in-house presto device, water existed out from the proximal glue joint of the catheter and balloon.Microscopic observation was performed and noted a circumferential break at the proximal glue joint.Therefore, the investigation has confirmed for the reported leak and identified break as the water leaks from the glue joint junction when the balloon inflated.The device break is the likely root cause of the device leak.The definitive cause of the identified device break could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly had a leak and break issue.It was further reported that the another balloon was used to complete the procedure.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: 11846933
• Report Number: 2020394-2021-01063
• Device Sequence Number: 3766659
• Product Code: LIT
• UDI-Device Identifier: 00801741058745
• UDI-Public: (01)00801741058745
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2021

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: Health Professional
• Device Model Number: DR13564
• Device Catalogue Number: DR13564
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other