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

Model Number	3243
Medical Device Problem Codes	Difficult to Flush (1251); Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005); Noise, Audible (3273); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the rotation speed was not stable.The target lesion was located in the proximal right coronary artery.A 1.50mm rotapro and rotawire were selected for use.During rotablation, the advancer was stuck in the middle and was unable to move distally.Additionally, there was no drop in speed on the console.An unexpected noise was heard.The set operational speed was 160k to 180k rpm however, the maximum speed reached was190k rpm.The rotapro burr was removed and attempted to be flushed, but was unsuccessful.The procedure was completed successfully using a replacement rotapro, and the same rotawire.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the returned product consisted of the rotapro atherectomy system.Visual inspection of the device did not identify any damages or defects.After destructive testing, it was found that the coil was kinked, stretched, and detached from the handshake connection within the sheath.Wear was identified within the sheath.In functional test, the advancer knob encountered resistance during attempted movement while the advancer and burr housing were connected.The housings were disconnected, and it was found that the handshake connection was within the burr catheter housing and could not be retrieved.After the burr housing was disconnected from the advancer, the advancer knob was able to move back and forth with no resistance or issues.During fluid infusion, there appeared to be a diminished flow of fluid beyond the damaged coil and handshake connection within the sheath.Product analysis confirmed the reported events, as the coil was kinked, stretched, and detached form the handshake connection within the sheath, creating resistance when attempting to adjust the advancer knob, and inhibiting the flow of fluid through the burr catheter.It was considered likely that the reported abnormal noise and high, unstable speeds were attributable to the separated coil, allowing the advancer to rotate at higher speeds without the burr catheter connected.
Event or Problem Description
It was reported that the rotation speed was not stable.The target lesion was located in the proximal right coronary artery.A 1.50mm rotapro and rotawire were selected for use.During rotablation, the advancer was stuck in the middle and was unable to move distally.Additionally, there was no drop in speed on the console.An unexpected noise was heard.The set operational speed was 160k to 180k rpm however, the maximum speed reached was190k rpm.The rotapro burr was removed and attempted to be flushed, but was unsuccessful.The procedure was completed successfully using a replacement rotapro, and the same rotawire.There were no patient complications reported.

• Brand Name: ROTAPRO
• Common Device Name: 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: 19059899
• Report Number: 2124215-2024-20882
• Device Sequence Number: 6029761
• Product Code: MCX
• UDI-Device Identifier: 08714729893363
• UDI-Public: 08714729893363
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2025
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0032135876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown