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

Model Number 3243

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

The returned product consisted of the rotablator rotalink burr catheter.131cm of the coil and sheath were returned for analysis.The handshake connection and burr housing were not returned for analysis.The sheath, coil, and burr were visually and microscopically examined.Inspection of the device found that blood was present within the device, the sheath was separated, and that the coil was kinked and detached.As the reported events indicate that the device was cut during attempts to remove the device, it was not considered likely that the reported stuck rotawire was attributable to these damages.A portion of the rotawire used in the procedure was returned for analysis and used for testing.During testing, the returned wire was able to be removed with resistance but was not able to be reinserted beyond the damaged end of the coil.In order to determine the functionality of the device, a test rotawire was used.During analysis, the test rotawire was unable to be inserted beyond the damaged portion of the coil.Product analysis could not confirm the reported events, as the device was received incomplete and clinical circumstances were not able to be replicated.As the reported events indicate that the device was cut during attempts to remove the device, it was not considered likely that the reported stuck rotawire was attributable to these damages.

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: ROTAPRO
• 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; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17737950
• MDR Text Key: 323300265
• Report Number: 2124215-2023-49715
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 08714729893356
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 11/07/2023

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: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0031827547
• 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: 10/17/2023
• Supplement Dates FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2023
• 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