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 06/28/2018

Event Type  Injury  

Event Description

It was reported that the patient experienced superficial femoral artery distal dissection after percutaneous transluminal angioplasty (pta). The patient was enrolled in the (b)(6) study with the patient identifier of (b)(6) on (b)(6) 2018. A target lesion located in the right distal superficial femoral artery (sfa). The lesion was 100% occluded with a reference vessel diameter of 4 mm, length of 50 mm and was classified as a tasc ii b lesion. The target lesion was treated with a 2. 1 mm jetstream xc atherectomy catheter and jetstream console. Post treatment, pta was performed, with 0% final residual stenosis. On (b)(6) 2018, same day of the index procedure post pta, dissection in the distal sfa was noted. This event could possibly be related to the jetstream devices. On (b)(6) 2018, the event was considered recovered/resolved. The patient had been discharged by 2 july 2018 with aspirin and clopidogrel. No action was taken to treat the event. No further complications were reported.

• 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: 8461299
• MDR Text Key: 140207521
• Report Number: 2134265-2019-03069
• 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
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• 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: 03/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/28/2019 Patient Sequence Number: 1