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

Model Number 45007

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

Patient Problem Vascular Dissection (3160)

Event Date 03/06/2019

Event Type  Injury  

Event Description

It was reported that a type b dissection occurred. The patient was enrolled into the jetstream china study on (b)(6) 2019. The target lesion located in the left mid superficial femoral artery (sfa) had 100% occlusion, reference vessel diameter of 5mm, and length of 112mm and was classified as tasc ii b lesion. The target lesion was treated with sc 1. 8mm and xc 2. 1/3. 0mm jetstream catheters. Post treatment, percutaneous transluminal ballon angioplasty (pta) was performed, with 20% final residual stenosis. On (b)(6) 2019, same day of the index procedure, post jetstream treatment with the xc 2. 1/3. 0mm catheter, a type b dissection was noted in the target lesion. Interventional procedure was performed to treat the event. On the same day, the event was considered to be recovered/resolved.

• Brand Name: JETSTREAM XC 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 CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8469577
• MDR Text Key: 140484496
• Report Number: 2134265-2019-02604
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K133023
• 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
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/14/2019
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0021375755
• 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: 04/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2017
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/01/2019 Patient Sequence Number: 1