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	09/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter address (b)(6).
Event or Problem Description
It was reported that an embolism occurred, requiring additional intervention.The 100% stenosed target lesion was located in a moderately tortuous and severely calcified superficial femoral artery (sfa).A 1.6mm jetstream sc catheter was selected for use in the endovascular therapy procedure to treat the lower extremity arterial disease.The jetstream sc catheter was used along with a jetstream xc catheter to cut the lesion in the sfa eight times.Plain old balloon angioplasty and treatment with a drug-coated followed.On final imaging, it was noticed that plaque-like substance had embolized near the tibioperoneal trunk and a peripheral embolization occurred.Aspiration and a balloon dilation were performed to resolve the peripheral embolism.

• 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: 15597482
• Report Number: 2124215-2022-40871
• Device Sequence Number: 2072230
• 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
• Report Date (Section B): 10/13/2022

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: 05/01/2024
• Device Model Number: 45006
• Device Catalogue Number: 45006
• Device Lot Number: 0029510936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• 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: Male