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

Model Number	3320
Medical Device Problem Codes	Entrapment of Device (1212); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr was stuck in lesion.The 85% stenosed, 60 mm x 3.00mm target lesion was located in the moderately tortuous and severely calcified left anterior descending artery (lad).A 1.75mm rotalink burr was selected for coronary interventional procedure.During the procedure, it was noted that the speed was not enough, and the burr was stuck in the lesion.The procedure successfully completed with another of the same device.There was no patient complication, and the patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.E1 - initial reporter address 1: (b)(6).
Additional Manufacturer Narrative
B5: describe event or problem updated.E1 - initial reporter facility name: (b)(6) e1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that the burr was stuck in lesion.The 85% stenosed, 60 mm x 3.00mm target lesion was located in the moderately tortuous and severely calcified left anterior descending artery (lad).A 1.75mm rotalink burr was selected for coronary interventional procedure.During the procedure, it was noted that the speed was not enough, and the burr was stuck in the lesion.The procedure successfully completed with another of the same device.There was no patient complication, and the patient was stable post procedure.It was further reported that the target and observed maximum rotational speed was 180,000 rpm.The rotalink burr and the rotawire were removed together as one unit from the patient.The patient was good post procedure.
Additional Manufacturer Narrative
B5: describe event or problem updated.D4: lot number: updated.E1 - initial reporter facility name: (b)(6) hospital.E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the device was returned for device analysis.Inspection of the device found that the sheath was pinched/kinked at 23cm and 24.3cm distal from the strain relief.Inspection of the device after destructive testing found that the handshake connection was within the sheath and was not retrievable due to the pinched sheath as the coil was not moveable.The handshake connection was not visible from the burr housing; therefore, the burr housing was dismantled for further inspection.Product analysis confirmed the reported failure to reach optimal speed as the sheath was found to be pinched which resulted in lack of movement to the coil which would cause rotational issues impacting speed.The handshake connection within the sheath was also not retrievable due to the lack of coil movement caused from the pinched sheath.Product analysis could not confirm the reported stuck in lesion as the clinical circumstances could not be replicated.
Event or Problem Description
It was reported that the burr was stuck in lesion.The 85% stenosed, 60 mm x 3.00mm target lesion was located in the moderately tortuous and severely calcified left anterior descending artery (lad).A 1.75mm rotalink burr was selected for coronary interventional procedure.During the procedure, it was noted that the speed was not enough, and the burr was stuck in the lesion.The procedure successfully completed with another of the same device.There was no patient complication, and the patient was stable post procedure.It was further reported that the target and observed maximum rotational speed was 180,000 rpm.The rotalink burr and the rotawire were removed together as one unit from the patient.The patient was good post procedure.

• Brand Name: ROTALINK BURR
• 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: 19533320
• Report Number: 2124215-2024-34686
• Device Sequence Number: 7606791
• Product Code: MCX
• UDI-Device Identifier: 08714729185840
• UDI-Public: 08714729185840
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2024

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: 08/20/2025
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0032255626
• 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: 05/24/2024
• Supplement Date Received by Manufacturer: 06/12/2024; 07/25/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/03/2024; 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2023
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Weight: 89 KG