MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DORADO®; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number DR135610

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/15/2019

Event Type  malfunction  

Event Description

The balloon was inflated in the right lower extremity and was thought to have ruptured after inflation.The balloon/catheter was removed from the patient.Upon inspection, the balloon portion was noted to have broken off the shaft.Using x-ray, the balloon was located inside the patient, in the artery, still on the wire.The physician used another balloon to help pull back and eventually retrieve the separated balloon.

• Brand Name: DORADO®
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st; tempe AZ 85281
• MDR Report Key: 8490915
• MDR Text Key: 141178276
• Report Number: 8490915
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DR135610
• Device Catalogue Number: DR135610
• Device Lot Number: 93UC0077
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2019
• Date Report to Manufacturer: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34310 DA