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	01/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the burr was stuck in lesion.The target lesion was located in the severely calcified left anterior descending artery.A 2.00mm rotalink burr was selected for use.During the procedure, it was noted that the burr stuck in the lesion and the speed dropped significantly.A guidezilla ii was used against the lesion to remove the entire system and the procedure was completed with another of the same device.There were no complications reported and the patient was stable post procedure.
Additional Manufacturer Narrative
E1.Initial reporter address (b)(6).Device evaluated by manufacturer: returned product consisted of the rotablator rotalink burr catheter.The handshake connection, sheath, coil, burr and annulus were visually examined.Inspection of the device did not identify any damages or defects.The advancer used in the procedure was not returned; analysis was performed using a test rotapro advancer.When the rotapro advancer was connected to the returned burr catheter and the rotapro console control system and the knob switch [ablation button] was pressed, the burr catheter was able to reach and maintain optimal rpm with no resistance or issues.Product analysis could not confirm the reported events, as the returned burr catheter was able to reach and maintain optimal rpm with no resistance or issues with a test advancer.Clinical circumstances were unable to be replicated.
Event or Problem Description
It was reported that the burr was stuck in lesion.The target lesion was located in the severely calcified left anterior descending artery.A 2.00mm rotalink burr was selected for use.During the procedure, it was noted that the burr stuck in the lesion and the speed dropped significantly.A guidezilla ii was used against the lesion to remove the entire system and the procedure was completed with another of the same device.There were no complications reported and the patient was stable 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16504470
• Report Number: 2124215-2023-10035
• Device Sequence Number: 20398098
• Product Code: MCX
• UDI-Device Identifier: 08714729126881
• UDI-Public: 08714729126881
• 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
• Report Date (Section B): 05/04/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/19/2023
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0028227104
• 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: 02/23/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 84 KG