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

Model Number	DR8082
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	12/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 04/2021).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured at nominal pressure.It was further reported that the pta balloon allegedly caused a tear in the left pulmonary artery which led to a pseudoaneurysm.There were no further reported complications to the patient.

• Brand Name: DORATO 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: 9530326
• Report Number: 2020394-2019-05875
• Device Sequence Number: 18935412
• Product Code: DQY
• UDI-Device Identifier: 00801741059179
• UDI-Public: (01)00801741059179
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K072283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DR8082
• Device Catalogue Number: DR8082
• Device Lot Number: 93QC0120
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 12/30/2019
• 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: Required Intervention