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

Model Number 2077-01

Device Problems Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Non specific EKG/ECG Changes (1817); Vascular Dissection (3160)

Event Date 08/18/2023

Event Type  Injury  

Event Description

It was reported that the patient had a dissection and st elevations.The target lesion was located in the severely tortuous and calcified right circumflex artery (rcx).A 1.25mm rotapro and rotawire were selected for use.During rotablation, the rotapro burr became stuck on the guidewire behind the stenosis of the target lesion.The physician attempted to advance a second wire down to assist with freeing the rotapro burr and rotawire, however the second wire was not able to cross.A dissection was then noted as well as st elevations.They then cut the burr catheter in order to try and retrieve the plastic sleeve, but this was also not possible.The physician then pulled the rotapro burr and rotawire together, removing them from the patient.The procedure was then completed successfully using an alternate method.The procedure had gone on longer than expected, however the patient is in good condition following the procedure.

Manufacturer Narrative

Returned product consisted of a portion of the rotawire drive.The rota device used in the procedure was returned through complaint (b)(4) with the rotawire within the device.The wire body, proximal end, and spring tip were visually and microscopically examined.Inspection of the device found that the rotawire was fractured and kinked at the proximal end.The returned portion of the rotawire was measured, and it was found that 145.5cm of the rotawire was returned.The damage observed to the wire was accounted for within the reported events.The advancer used during the procedure was returned and used for analysis.The returned wire was able to be removed with resistance but was not able to be reinserted due to the damage at the proximal end of the rotawire.Product analysis could not confirm the reported event, as the damages to the returned device were accounted for within the reported events as part of attempted removal, and clinical circumstances were unable to be replicated.

Event Description

It was reported that the patient had a dissection and st elevations.The target lesion was located in the severely tortuous and calcified right circumflex artery (rcx).A 1.25mm rotapro and rotawire were selected for use.During rotablation, the rotapro burr became stuck on the guidewire behind the stenosis of the target lesion.The physician attempted to advance a second wire down to assist with freeing the rotapro burr and rotawire, however the second wire was not able to cross.A dissection was then noted as well as st elevations.They then cut the burr catheter in order to try and retrieve the plastic sleeve, but this was also not possible.The physician then pulled the rotapro burr and rotawire together, removing them from the patient.The procedure was then completed successfully using an alternate method.The procedure had gone on longer than expected, however the patient is in good condition following the procedure.

• 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; 302 parkway, global park; la aurora heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17738053
• MDR Text Key: 323301960
• Report Number: 2124215-2023-49734
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/13/2023
• Supplement Dates Manufacturer Received: 10/26/2023
• Supplement Dates FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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