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 Code	Embolism/Embolus (4438)
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 additional intervention.A jetstream atherectomy catheter was selected for an atherectomy procedure.During the procedure, however, a distal embolization occurred.An additional aspiration procedure was performed to release the embolization.The procedure was successfully completed.No further complications were reported.
Additional Manufacturer Narrative
Sections updated in first supplemental report: b3- date of event corrected to (b)(6) 2022; b5- additional information added; d1- brand name corrected to jetstream sc; d4- model number corrected to 45006, lot number corrected to 0029298089, catalog number corrected to 45006; d4- added unique identifier ((b)(4)) ; g4- added premarket / 510(k)# (k133023); h4- added device manufacture date (04/29/2022).
Event or Problem Description
It was reported that a distal embolization occurred, requiring additional intervention.A jetstream atherectomy catheter was selected for an atherectomy procedure.During the procedure, however, a distal embolization occurred.An additional aspiration procedure was performed to release the embolization.The procedure was successfully completed.No further complications were reported.It was further reported from duplicate event (report number 2124215-2022-56629) that 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.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.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16274584
• Report Number: 2124215-2023-02916
• Device Sequence Number: 14960856
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2023

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: 01/05/2023
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 03/07/2023
• 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: Unknown