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

Model Number 45007

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

(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 2.4mm jetstream xc catheter was selected for use in the endovascular therapy procedure to treat the lower extremity arterial disease.The jetstream xc catheter was used along with a jetstream sc catheter to cut the lesion in the sfa eight times.Plain old balloon angioplasty and treatment with a drug-coated balloon 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 XC
• 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: 15597428
• MDR Text Key: 301668599
• Report Number: 2124215-2022-40859
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: 08714729889922
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2024
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0029655334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2022
• 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