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 Problems Embolism (1829); Vascular Dissection (3160)

Event Date 06/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6). Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed. (b)(4).

Event Description

Jetstream (b)(6) study. It was reported that the patient experienced a distal embolization in the target limb. The 100% stenosed, 5. 0mmx60mm, tasc ii b target classified lesion was located in the left distal superficial femoral artery. The lesion was treated with a 2. 1 mm jetstream xc atherectomy catheter. A distal embolization of the target limb was detected through angiography in the anterior tibial artery. Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed, with 10% final residual stenosis. The event was treated with the help of thrombus aspiration and pta. The subject was discharged.

• Brand Name: JETSTREAM XC ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; model farm road; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 7710999
• MDR Text Key: 114730111
• Report Number: 2134265-2018-06528
• 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,Followup
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• 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: 09/13/2019
• 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?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/23/2018 Patient Sequence Number: 1