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

Model Number 45006

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Embolism/Embolus (4438)

Event Date 09/21/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter address (b)(6).

Event 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
• Type of Device: 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
• MDR Text Key: 301668971
• Report Number: 2124215-2022-40871
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889830
• UDI-Public: 08714729889830
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male