FDA Adverse Event Injury Summary report: N

ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

MDR report key: 1891114 · Received November 4, 2010

Report

Report Number: 2134265-2010-04910
Event Type: Injury
Date Received: November 4, 2010
Date of Event: October 6, 2010
Report Date: October 12, 2010
Manufacturer: BOSTON SCIENTIFIC - CORK
Product Code: MCX
PMA / PMN Number: P900056
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE COMPLAINT UNIT WAS NOT CARRIED OUT AS THE PRODUCT WAS NOT RETURNED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) PROCEDURE, THE BURR BECAME STUCK IN THE LESION. VASCULAR ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. THE LESIONS WERE LOCATED IN THE MODERATE TO SEVERELY CALCIFIED AND MODERATELY TORTUOUS DISTAL LEFT ANTERIOR DESCENDING (LAD) AND DISTAL LEFT CIRCUMFLEX (LCX) ARTERY. THE ATLANTIS SR PRO2 CORONARY IMAGING CATHETER DID NOT CROSS THE LESION. THE LESION WAS DILATED WITH AN UNSPECIFIED BALLOON CATHETER; HOWEVER THE DILATATION WAS NOT SUFFICIENT. THE 1.50MM ROTALINK PLUS WAS ADVANCED TO THE LESION FOR ROTATIONAL ATHERECTOMY BUT AFTER 5 CYCLES OF ROTATIONAL ABLATION THE BURR BECAME STUCK IN THE LESION FOR 6 MINUTES. THE BURR WAS REMOVED IN DYNAGLIDE SEPARATE FROM THE ROTAWIRE. NO FURTHER PATIENT COMPLICATION WAS REPORTED AND THE PATIENT STATUS IS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM	CATHETER, CORONARY, ATHERECTOMY	MCX	BOSTON SCIENTIFIC - CORK	H749236310030

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other	ATLANTIS SR PRO2