MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK JETSTREAM® XC ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 112264-003

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

Patient Problem Embolism (1829)

Event Date 06/26/2018

Event Type  Injury  

Manufacturer Narrative

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

The patient was enrolled in (b)(6) study.It was reported that a distal embolism occurred.The jetstream system was used for an atherectomy procedure in the anterior tibial artery, following percutaneous transluminal angioplasty (pta).During the index procedure, a distal embolization was detected through angiography in the target limb.The embolization was treated with endovascular pta and thrombus aspiration.The same day the event was considered to be resolved following treatment.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the target lesion was the right mid superficial femoral artery.The target lesion was 100% stenosed and had a reference diameter of 4mm, a length of 60mm, and was classified as a tasc ii a lesion.A 2.1mm jetstream xc atherectomy catheter was selected for use for the atherectomy procedure.A 1.85 jetstream xc atherectomy catheter was also used for treatment during the procedure.Residual stenosis following use of the jetstream was 20%.After post-treatment percutaneous transluminal angioplasty was performed, residual stenosis was 0%.

• Brand Name: JETSTREAM® XC ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork MN ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7733254
• MDR Text Key: 115521435
• Report Number: 2134265-2018-06718
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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,Followup
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2019
• Device Model Number: 112264-003
• Device Catalogue Number: PV31300
• Device Lot Number: 21375755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2018
• 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: N
• Patient Sequence Number: 1
• Patient Age: 82 YR