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	10/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that the procedure was cancelled.The 90% stenosed target lesion was located in the left anterior descending artery.A ce rotablator atherectomy systems and devices was selected for use.After connecting all the connection with the rota console, it was noted that the foot pedal in dynaglide mode was not working.The cylinder pressure was good and other connection was also fine.The patient was under general anesthesia when the issue happened.The procedure was rescheduled after 3 days.There were no patient complications reported.
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).Device evaluated by manufacturer: the rotablator dynaglide foot pedal was returned for analysis.The foot pedal, body, tubing, and connectors were visually examined.Inspection of the unit found that the dynaglide connector was broken/damaged.Further functional testing was unable to be performed due to the damaged dynaglide connector preventing the returned foot pedal from connecting to the test console.Product analysis could not confirm the reported events as the damaged dynaglide connector prevented the foot pedal from connecting to the console.It was considered likely that the reported events were attributable to the damaged connector.
Event or Problem Description
It was reported that the procedure was cancelled.The 90% stenosed target lesion was located in the left anterior descending artery.A ce rotablator atherectomy systems and devices was selected for use.After connecting all the connection with the rota console, it was noted that the foot pedal in dynaglide mode was not working.The cylinder pressure was good and other connection was also fine.The patient was under general anesthesia when the issue happened.The procedure was rescheduled after 3 days.There were no patient complications reported.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that the procedure was cancelled.The 90% stenosed target lesion was located in the left anterior descending artery.A ce rotablator atherectomy systems and devices was selected for use.After connecting all the connection with the rota console, it was noted that the foot pedal in dynaglide mode was not working.The cylinder pressure was good and other connection was also fine.The patient was under general anesthesia when the issue happened.The procedure was rescheduled after 3 days.There were no patient complications reported.

• Brand Name: ROTABLATOR
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): EP TECHNOLOGIES, INC.; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 15687551
• Report Number: 2124215-2022-42613
• Device Sequence Number: 15158916
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2023

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 Model Number: 3360
• Device Catalogue Number: 3360
• Device Lot Number: OEMTRACE
• 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: 10/10/2022
• Supplement Date Received by Manufacturer: 05/26/2023; 07/13/2023
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 06/15/2023; 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown