MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE DRIVE; CATHETER, CORONARY, ATHERECTOMY

Model Number 2077-01

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 07/10/2023

Event Type  Injury  

Event Description

It was reported that the burr was stuck in the lesion, requiring additional intervention.A rotawire drive and a 1.25 rotapro were selected for use.During the procedure, it was noted that the burr could not advance on the wire.Furthermore, a kink was noted on the wire.The physician attempted to use another rotawire drive, however, the same issue occurred.It was then noted the rotapro burr was stuck in the lesion.The physician made several attempts to maneuver and remove the rotapro burr, but the rotapro burr could not be removed from the vessel.The procedure was cancelled, and the patient underwent emergency open-heart surgery to remove the device.

• Brand Name: ROTAWIRE DRIVE
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17432717
• MDR Text Key: 320113334
• Report Number: 2124215-2023-39969
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/31/2023

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
• Device Operator: Health Professional
• Device Model Number: 2077-01
• Device Catalogue Number: 2077-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 08/01/2023
• 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