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

Model Number	3360
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.The target lesion was located in the calcified vessel.A dynaglide foot pedal was selected for use.After the patient was sedated, it was noted that the foot pedal was not working as the connecter of dynaglide was damaged.The procedure was not completed due to this event.The patient was discharged without performing the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The foot pedal was received with the upper portion of dynaglide connector missing.Functional test was not performed because the complaint was confirmed by visual inspection.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the procedure was cancelled.The target lesion was located in the calcified vessel.A dynaglide foot pedal was selected for use.After the patient was sedated, it was noted that the foot pedal was not working as the connecter of dynaglide was damaged.The procedure was not completed due to this event.The patient was discharged without performing the procedure.No patient complications were reported.

• Brand Name: ROTABLATOR
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11348942
• Report Number: 2134265-2021-02022
• Device Sequence Number: 19862771
• Product Code: MCX
• UDI-Device Identifier: 08714729353317
• UDI-Public: 08714729353317
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2021

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 Model Number: 3360
• Device Catalogue Number: 3360
• Device Lot Number: FP45665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 10/06/2021
• Patient Sequence Number: 1