MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY

Device Problem Entrapment of Device (1212)

Patient Problem Extravasation (1842)

Event Date 01/14/2022

Event Type  Injury  

Event Description

It was reported that the burr was stuck on wire.The target lesion was located in a non-tortuous and moderately calcified tibial artery.A 1.25mm peripheral rotalink plus and rotawire was selected for use.During the procedure, advancement was fine, but when the device entered the dense plaque, the advancer made a loud grinding noise so the physician stopped.The device was removed but it got stuck on the wire and would not come off.The burr and the wire were pulled out together and intact using dynaglide mode.A contrast run was performed afterwards and an extravasation of the vessel was found.It was uncertain if it was the burr or that the patients vessel was so diseased that actually caused the extravasation.It was noted that it might have been the plaque and the burr got trapped and couldn't spin and got hung up on the wire.A sterling balloon catheter was used to complete the procedure.There were no complications reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of the rotawire drive.The rotawire was received within the peripheral rotalink plus.The guidewire was able to be removed from the returned device with resistance due to multiple kinks in the wire.The wire body, proximal end, and spring tip were visually and microscopically examined.Inspection of the device found that the guidewire was kinked at 95cm and 137cm from the spring tip.The advancer used during the procedure was returned, so analysis was performed using the returned advancer.The returned wire was able to be reinserted into the test advancer and removed with resistance due to the identified kinks in the wire.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13447782
• MDR Text Key: 285041928
• Report Number: 2134265-2022-00845
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2022

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2022
• Initial Date FDA Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2022
• 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