FDA Adverse Event Injury Summary report: N

JETSTREAM® XC ATHERECTOMY CATHETER

MDR report key: 6149420 · Received December 6, 2016

Report

Report Number: 2134265-2016-11042
Event Type: Injury
Date Received: December 6, 2016
Date of Event: September 13, 2016
Report Date: November 11, 2016
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: MCW
PMA / PMN Number: K130637
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MFR.: THE DEVICE WAS NOT RETURNED 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).

Description of Event or Problem · 1

SAME CASE AS: 2134265-2016-11043. (B)(4) . ON (B)(6) 2016. IT WAS REPORTED THAT THERE WAS RESTENOSIS OF THE LESION. AN 2.1 MM JETSTREAM® XC ATHERECTOMY CATHETER AND A 2.4 MM JETSTREAM® XC ATHERECTOMY CATHETER WERE SELECTED FOR AN ATHERECTOMY PROCEDURE IN THE DISTAL SUPERFICIAL FEMORAL ARTERY IN (B)(6) 2014. THE LESION WAS 6 MM X 40 MM, HAD 90% STENOSIS AND WAS CLASSIFIED AS A TASC II LESION. A PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY (PTA) WAS PERFORMED. THERE WAS 0% FINAL RESIDUAL STENOSIS FOLLOWING THE INITIAL PROCEDURE. HOWEVER, IN (B)(6) 2016, 91 DAYS POST PROCEDURE, RIGHT SUPERFICIAL FEMORAL ARTERY RESTENOSIS WAS OBSERVED. THIS WAS ASSESSED AS POSSIBLY RELATED TO THE JETSTREAM DEVICES. NO FURTHER ACTION WAS TAKEN AS OF THE TIME OF THE REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
799379	JETSTREAM® XC ATHERECTOMY CATHETER	CATHETER, PERIPHERAL, ATHERECTOMY	MCW	BOSTON SCIENTIFIC - MAPLE GROVE	112264-001	18822093

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR		Other