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

Model Number	3241
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that burr separation occurred.The 90% stenosed target lesion was located in moderately tortuosity and mildly to moderately calcified the proximal left circumflex artery (lcx).A 1.75mm rotablator plus was selected for the percutaneous coronary intervention (pci) procedure.The rotablator was prepped and platformed at 180000 rpm outside the patient.During advancement, there was no resistance.After ablation successfully completed, the physician noted that the burr became separated from the shaft while the burr was still inside the patient.There was a degree of deceleration and device stall prior to becoming detached.The device was pulled out with the rotawire and the procedure was completed with this device.There were no patient complications and the patient status was stable.
Event or Problem Description
It was reported that burr separation occurred.The 90% stenosed target lesion was located in moderately tortuosity and mildly to moderately calcified the proximal left circumflex artery (lcx).A 1.75mm rotablator plus was selected for the percutaneous coronary intervention (pci) procedure.The rotablator was prepped and platformed at 180000 rpm outside the patient.During advancement, there was no resistance.After ablation successfully completed, the physician noted that the burr became separated from the shaft while the burr was still inside the patient.There was a degree of deceleration and device stall prior to becoming detached.The device was pulled out with the rotawire and the procedure was completed with this device.There were no patient complications and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of the rotablator rotalink plus atherectomy system.The burr catheter was received attached to the advancer unit.The rotawire used in the procedure was received within the rotablator device.The advancer, handshake connections, sheath, coil, and burr were visually and microscopically examined.Visual and microscope inspection of the device revealed that the coil was stretched and broken at the point of burr detachment.Functional testing was performed by attempting to rotate the drive shaft and the drive shaft was able to rotate.Then, the functional testing was performed by connecting the rotablator advancer to the rotablator control console system.When the foot pedal was pushed, the advancer was not able to run, so it did not get any speed and a stall error was displayed on the console.The advancer was dismantled for inspection, but no damage or irregularities were identified.Inspection of the remainder of the device, revealed no other damage or irregularities.

• Brand Name: ROTALINK PLUS
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13385598
• Report Number: 2134265-2022-00780
• Device Sequence Number: 1702554
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: 08714729228370
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P900056
• 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): 03/31/2022

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: 06/09/2023
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0027636703
• 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: 01/21/2022
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2021
• 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