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

Catalog Number UNKNOWN DR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Great Vessel Perforation (2152); Vascular Dissection (3160)

Event Type  Injury  

Manufacturer Narrative

The events are part of a retrospective study.Flow-limiting dissections and vessel perforation requiring intervention is captured.As the lot numbers for the devices were not provided, a manufacturing review could not be performed.The samples were not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported events is inconclusive.Based upon the available information, the definitive root cause for these events 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.

Event Description

It was reported in a post-market clinical follow-up survey on pta balloon dilatations, 68% flow-limiting dissection and 1 vessel perforations occurred.It was further reported that the medical intervention was required to treat the patients.The current patients' status is unknown.

• Brand Name: DORADO 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: 10047838
• MDR Text Key: 190652817
• Report Number: 2020394-2020-03390
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072283
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN DR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2020
• 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