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

Model Number	3280
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.The target lesion was located in the left anterior descending artery.A rotalink advancer with tubular drive shaft was selected for use.During the procedure, the device was damaged along with the burr and due to this event the procedure was cancelled.There were no complications reported and the patient was stable post procedure.
Event or Problem Description
It was reported that the procedure was cancelled.The target lesion was located in the left anterior descending artery.A rotalink advancer was selected for use.During the procedure, the device was damaged along with the burr and due to this event, the procedure was cancelled.There were no complications reported and the patient was stable post procedure.It was further reported that the advancer did not function.The procedure was completed by using another same device.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The body and handshake connection of the advancer were visually and microscopically examined.Per inspection of the device, there were no damages or defects being identified.Also, a functional test was conducted by using a test burr catheter during analysis as the burr catheter used in the procedure was not returned.When the test burr catheter was connected to the advancer, the advancer was connected to the rotablator console control system, and the foot pedal was pressed, the advancer was able to reach and maintain optimal revolutions per minute (rpm) with no resistance or issues.Product analysist could not confirm the reported event, as the device was able to reach and maintain optimal rpm with no resistance or issues using a test burr catheter, and clinical circumstances were unable to be replicated.
Event or Problem Description
It was reported that the procedure was cancelled.The target lesion was located in the left anterior descending artery.A rotalink advancer was selected for use.During the procedure, the device was damaged along with the burr and due to this event, the procedure was cancelled.There were no complications reported and the patient was stable post procedure.It was further reported that the advancer did not function.The procedure was completed by using another same device.

• Brand Name: ROTALINK ADVANCER
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15552258
• Report Number: 2124215-2022-39282
• Device Sequence Number: 19579297
• Product Code: MCX
• UDI-Device Identifier: 08714729317739
• UDI-Public: 08714729317739
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2023

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: 10/25/2023
• Device Model Number: 3280
• Device Catalogue Number: 3280
• Device Lot Number: 0028443723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 10/12/2022; 12/14/2022
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 10/27/2022; 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2021
• 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 Age: 59 YR
• Patient Sex: Female
• Patient Weight: 60 KG