MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM SC; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	45006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Embolism/Embolus (4438); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a distal embolization occurred, requiring intervention.A jetstream sc catheter, 1.6mm and a jetstream xc catheter, 2.1mm were selected for an endovascular treatment.However, a distal embolization occurred in the left anterior tibial artery during the procedure.Percutaneous intervention was performed and the patient was in recovery.
Event or Problem Description
It was reported that a distal embolization occurred.A jetstream sc catheter, 1.6mm and a jetstream xc catheter, 2.1mm were selected for an endovascular treatment.However, a distal embolization occurred in the left anterior tibial artery during the procedure.Percutaneous intervention was performed and the patient was in recovery.It was further reported that there were no device-related performance issues observed; however, the physician believed both jetstream catheters were related to the embolization.The patient has recovered after the procedure.
Additional Manufacturer Narrative
B5, h6 updated in second supplemental report.
Event or Problem Description
It was reported that a distal embolization occurred.A jetstream sc catheter, 1.6mm and a jetstream xc catheter, 2.1mm were selected for an endovascular treatment.However, a distal embolization occurred in the left anterior tibial artery during the procedure.Percutaneous intervention was performed and the patient was in recovery.It was further reported that there were no device-related performance issues observed; however, the physician believed both jetstream catheters were related to the embolization.The patient has recovered after the procedure.It was further reported that this event is a duplicate to the event reported in report number 2124215-2023-02916.Report number 2124215-2023-02916 will capture the events and any subsequent additional information for this event.

• Brand Name: JETSTREAM SC
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16198810
• Report Number: 2124215-2022-56629
• Device Sequence Number: 5794732
• Product Code: MCW
• UDI-Device Identifier: 08714729889830
• UDI-Public: 08714729889830
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/29/2024
• Device Model Number: 45006
• Device Catalogue Number: 45006
• Device Lot Number: 0029298089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/24/2022
• Supplement Date Received by Manufacturer: 01/20/2023; 02/10/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 01/20/2023; 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2022
• 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 Sex: Female