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

Model Number	DR8064
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one sample was returned for evaluation and was noted to be bloody.The proximal balloon glue joint was noted to have a circumferential break from which water was noted to be leaking.Therefore, the investigation is confirmed for circumferential break as a break was noted to the proximal balloon joint during evaluation.The investigation is inconclusive for the reported balloon rupture, as the balloon itself was noted to be inflated during evaluation.The definitive root cause for the reported balloon rupture and break could not be determined based upon available 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.(expiry date: 09/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured at 8 atm on the first inflation attempt.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: 12057228
• Report Number: 2020394-2021-01248
• Device Sequence Number: 3502576
• Product Code: LIT
• UDI-Device Identifier: 00801741058721
• UDI-Public: (01)00801741058721
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/22/2021

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: DR8064
• Device Catalogue Number: DR8064
• Device Lot Number: 93WE0077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 06/24/2021
• 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