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

Model Number	3241
Medical Device Problem Codes	Material Deformation (2976); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.The stenosed target lesion was located in the severely tortuous and calcified middle left anterior descending artery (lad).A 1.75mm rotablator plus was selected for use.During the procedure, it was noted that the device was kinked due to angulation when crossing the lesion and it got stalled.The procedure was not completed due to this event.There were no complications reported and the patient was stable.
Event or Problem Description
It was reported that the procedure was cancelled.The stenosed target lesion was located in the severely tortuous and calcified middle left anterior descending artery (lad).A 1.75mm rotablator plus was selected for use.During the procedure, it was noted that the device was kinked due to angulation when crossing the lesion and it got stalled.The procedure was not completed due to this event.There were no complications reported and the patient was stable.
Additional Manufacturer Narrative
The device was returned and evaluated by manufacturer.Inspection of the device did not identify any damages or defects.Inspection of the device after destructive testing found that the turbine was corroded.It was considered likely that the corrosion to the device identified during analysis was caused by the drying of the saline infusion that had been used during the procedure.As the rotawire used in the procedure was returned and used for analysis.During analysis, the rotawire had resistance during removal due to kinks present on the wire.Due to the severity of the kink damage, reinsertion was not completed.When the rotablator advancer was connected to the rotablator console and the foot pedal was pressed, the device stalled and would not run.After destructive testing was performed, it was found that the shutter was damaged.The damage present could lead to fiberoptic interference.Design assurance and cork supplier quality were contacted, and it was verified that the shutter damage present was likely due to a molding defect from supplier.

• Brand Name: ROTALINK PLUS
• 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: 19944737
• Report Number: 2124215-2024-46961
• Device Sequence Number: 18171086
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: 08714729228370
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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: 10/24/2024
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0030596704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2022
• 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: Male