MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM PVCN100; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	45010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	04/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a vessel dissection occurred, requiring additional intervention.On (b)(6) 2021, the subject was enrolled into (b)(6) study and the index procedure was performed on the same day.A target lesion located in the right distal superficial femoral artery (sfa) had 95% occlusion, reference vessel diameter of 4mm, length of 30mm, and it was classified as a tasc ii a lesion.The target lesion was treated with a 2.1/3.0mm jetstream catheter.The residual stenosis post jetstream atherectomy was 100%.Post treatment, percutaneous transluminal angioplasty (pta) was performed, with 0% final residual stenosis.On (b)(6) 2021, during the index procedure, post treatment of target lesion with jetstream catheter, an f-type dissection of the sfa target lesion was noted.Pta and stenting were performed in the target vessel to treat the event.On (b)(6) 2021, the event was considered to be recovered/resolved.On (b)(6) 2021, the subject was discharged on aspirin and clopidogrel.

• Brand Name: JETSTREAM PVCN100
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11924256
• Report Number: 2134265-2021-07154
• Device Sequence Number: 847881
• Product Code: MCW
• UDI-Device Identifier: 08714729890430
• UDI-Public: 08714729890430
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K130637
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2021

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: 45010
• Device Catalogue Number: 45010
• Device Lot Number: JET0464
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2021
• Initial Report FDA Received Date: 06/02/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR