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 Codes	Embolism (1829); Vascular Dissection (3160)
Date of Event	06/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Jetstream (b)(6) study.It was reported that the patient experienced a distal embolization in the target limb.The patient was enrolled into the jetstream (b)(6) study on (b)(6) 2018 and the index procedure was performed on (b)(6) 2018.The 100% stenosed, 5.0mmx60mm, tasc ii b target classified lesion was located in the left distal superficial femoral artery (sfa).The lesion was treated with a 2.1 mm jetstream xc atherectomy catheter and a jetstream console.Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed, with 10% final residual stenosis.On (b)(6) 2018, a distal embolization of the target limb was detected through angiography in the anterior tibial artery.The event was treated with thrombus aspiration and endovascular pta.On the same day, the subject was also noted with class b superficial femoral artery dissection.No actions were taken to treat the event.The event was considered to be recovered/resolved.On (b)(6) 2018, 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: 10025216
• Report Number: 2134265-2020-05990
• Device Sequence Number: 2937897
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2020

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: JET0552
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 05/05/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR