FDA Adverse Event Injury Summary report: N

ROTALINK CATHETER

MDR report key: 1111878 · Received August 12, 2008

Report

Report Number
2134265-2008-02282
Event Type
Injury
Date Received
August 12, 2008
Date of Event
July 18, 2008
Report Date
July 21, 2008
Manufacturer
BOSTON SCIENTIFIC
Product Code
MCX
PMA / PMN Number
P900056
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
MN, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY AND ATHERECTOMY PROCEDURE, REMOVAL DIFFICULTIES AND A DISSECTION OCCURRED. THE 80-90% STENOSED LESIONS BEING TREATED WERE LOCATED IN THE PROXIMAL AND DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). ONE ABLATION RUN WAS PERFORMED WITH THE ROTALINK 1.75MM BURR ON THE PROXIMAL LESION FOR 24 SECONDS. THREE ABLATIONS RUNS WERE PERFORMED WITH THE ROTALINK 1.75MM BURR ON THE DISTAL LESION, 25 SECONDS, 33 SECONDS AND 40 SECONDS CONSECUTIVELY. DURING THE FINAL RUN IN THE DISTAL LESION, THE ROTALINK 1.75MM BURR MADE NOISE AND THE PHYSICIAN ENCOUNTERED DIFFICULTY REMOVING THE BURR. THE PHYSICIAN THEN DEEP-SEATED THE GUIDE CATHETER IN ORDER TO REMOVE THE BURR. A TYPE C DISSECTION WAS NOTED, BUT AS THE PATIENT WAS ASYMPTOMATIC AND HEMODYNAMICALLY STABLE, THE PHYSICIAN OPTED TO NOT TREAT THE DISSECTION. THE PROCEDURE WAS COMPLETED WITH MULTIPLE DEPLOYMENTS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS WAS REPORTED AS 'FINE'.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ROTALINK CATHETER MCX CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CVA21

Patients

Seq Age Sex Outcome Treatment
1 79 YR Other