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

Model Number 112266-001

Device Problem Insufficient Information (3190)

Patient Problems Swelling (2091); Alteration In Body Temperature (2682)

Event Date 10/25/2012

Event Type  Injury  

Manufacturer Narrative

Device evaluated by manufacturer: the complaint device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

(b)(6) registry.It was reported the patient experienced swelling and a hot leg post procedure.The 100% stenosed, 13cm in length, de novo target lesion located in the left popliteal artery with a reference diameter of 44mm.This jetstream xc atherectomy catheter was selected to treat the target lesion with a residual stenosis of 30%.However, the device stall half way up the popliteal artery, there was no loss of aspiration.No further actions were taken.In (b)(6) 2012, four days post index procedure the patient complained of swelling and a hot leg.A doppler study was performed and the results were negative.

• Brand Name: JETSTREAM® XC ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5293463
• MDR Text Key: 33402773
• Report Number: 2134265-2015-08505
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 112266-001
• Device Catalogue Number: PV41340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2015
• 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: N
• Patient Sequence Number: 1
• Patient Age: 65 YR