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	07/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that distal embolization occurred after using jetstream.The 100% stenosed target lesion was a chronic total occlusion (cto) that was severely calcified and located in the moderately tortuous superficial femoral artery (sfa).The lesion was ablated with a 1.6mm jetstream sc catheter.The lesion was dilated with a 6mm balloon but there remained severe stenosis with calcification.The jetstream was sized up to a 2.1/3.0mm, and lesion was dilated with a 6mm balloon.Angiography showed no flow.After deploying a 6.0/150mm eluvia drug-eluting stent, flow was recovered.Final angiogram showed mild flow limit in foot, but it was considered acceptable.Right ankle-brachial index (abi) improved from 0.46 to 0.99.The patient underwent 5th toe amputation two weeks later and was discharged two months later.
Additional Manufacturer Narrative
B3: date of event estimated using first day of aware month.
Additional Manufacturer Narrative
B3: date of event estimated using first day of aware month.Investigation results: ship history review: a ship history review for the reported upn was performed for the reporting customer.Batches from a 3-year period preceding the procedure date were reviewed, and no manufacturing deviations were identified that could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a review of the jetstream device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of 'known inherent risk of device.'.
Event or Problem Description
It was reported that distal embolization occurred after using jetstream.The 100% stenosed target lesion was a chronic total occlusion (cto) that was severely calcified and located in the moderately tortuous superficial femoral artery (sfa).The lesion was ablated with a 1.6mm jetstream sc catheter.The lesion was dilated with a 6mm balloon but there remained severe stenosis with calcification.The jetstream was sized up to a 2.1/3.0mm, and lesion was dilated with a 6mm balloon.Angiography showed no flow.After deploying a 6.0/150mm eluvia drug-eluting stent, flow was recovered.Final angiogram showed mild flow limit in foot, but it was considered acceptable.Right ankle-brachial index (abi) improved from 0.46 to 0.99.The patient underwent 5th toe amputation two weeks later and was discharged two months later.

• Brand Name: JETSTREAM SC
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 20023388
• Report Number: 2124215-2024-51643
• Device Sequence Number: 7335976
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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 Model Number: 45006
• Device Catalogue Number: 45006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 04/08/2026
• 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 Age: 81 YR
• Patient Sex: Male