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

Model Number 45010

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

Patient Problems Embolism (1829); Vascular Dissection (3160)

Event Date 05/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a distal embolization and grade c dissection occurred. The patient was enrolled in the (b)(6) study with the patient identifier of (b)(6). As part of the study, the patient underwent treatment on (b)(6) 2019. The target lesion was located in the left mid to distal superficial femoral artery (sfa) and was 80% occluded, a reference vessel diameter of 4 mm, length of 150 mm and classified as a tasc ii a lesion. The target lesion was treated with a jetstream pv atherectomy system console and a 2. 1mm jetstream xc atherectomy catheter and there was 40% residual stenosis. Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed, with 20% final residual stenosis. During the index procedure, distal embolization of the target lesion was noted. The location of embolization was found to be 2-5 cm away from the lower margin of the target lesion with no symptoms. Post embolization, blood flow was slow. The embolization was treated with angiography and endovascular intervention; percutaneous transluminal angioplasty (pta) and stenting. The embolization was considered recovered/resolved on the same day. Also during this procedure, a grade c dissection of the target lesion was noted post pta. No action was taken to treat this event. At the time of reporting, the event was recovering/ resolving. No further complications were reported.

• Brand Name: JETSTREAM PVCN100
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): EP TECHNOLOGIES, INC.; 150 baytech drive; san jose CA 95134
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8667000
• MDR Text Key: 146937331
• Report Number: 2134265-2019-06306
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 45010
• Device Catalogue Number: 45010
• Device Lot Number: JET0552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2017
• Is the Device Single Use?: No

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 06/04/2019 Patient Sequence Number: 1