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

Model Number DR8082

Device Problem Material Rupture (1546)

Patient Problem Pseudoaneurysm (2605)

Event Date 12/03/2019

Event Type  Injury  

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 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
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens TX 75751
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9530326
• MDR Text Key: 175112258
• Report Number: 2020394-2019-05875
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741059179
• UDI-Public: (01)00801741059179
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K072283
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DR8082
• Device Catalogue Number: DR8082
• Device Lot Number: 93QC0120
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention