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

Model Number 45006

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

Patient Problem Embolism (1829)

Event Date 06/26/2018

Event Type  Injury  

Event Description

It was reported that a distal embolization occurred.The patient was enrolled in the jetstream china study.The target lesion was located in the right mid superficial femoral artery (sfa) and was 100% occluded, a reference vessel diameter of 4 mm, length of 60 mm and classified as a tasc ii a lesion.The target lesion was treated with a 1.85mm jetstream sc atherectomy catheter and a 2.1/3.0 mm jetstream xc atherectomy catheter.Residual stenosis post jetstream atherectomy was 20%.Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed, with 0% final residual stenosis.In june 2018, same day as the index procedure (post pta), anterior tibial artery embolization of the target limb was noted.The embolization was detected through angiography.The event was treated with the help of endovascular pta and thrombus aspiration.The event was considered to be recovered/resolved.No further complications were reported.The patient was discharged.

• Brand Name: JETSTREAM SC ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9375970
• MDR Text Key: 168009374
• Report Number: 2134265-2019-14392
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K130637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2019

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 Model Number: 45006
• Device Catalogue Number: 45006
• Device Lot Number: 0021394585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2017
• 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 Age: 82 YR