ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

Report

Report Number: 2134265-2011-00093
Event Type: Injury
Date Received: January 18, 2011
Date of Event: December 16, 2010
Report Date: January 3, 2011
Manufacturer: BOSTON SCIENTIFIC - COSTA RICA
Product Code: MCX
PMA / PMN Number: P900056
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MFR.: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

Description of Event or Problem · 1

SAME CASE AS MFR. 2134265-2011-00029. (B)(4). IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX (LCX) ARTERY. THE LESION WAS PRE DILATED WITH A NON-BSC BALLOON CATHETER. A ROTAWIRE FLOPPY GUIDE WIRE AND A 1.25MM ROTALINK PLUS BURR WERE ADVANCED TO THE TARGET LESION. MULTIPLE ABLATIONS WERE SUCCESSFULLY PERFORMED HOWEVER; UPON THE LAST ABLATION THE GUIDE WIRE BECAME ENTRAPPED IN THE LESION. THE GUIDE WIRE AND THE DISTAL PART OF THE BURR WERE SEVERED FROM THE DELIVERY CATHETER AND REMAINED IN THE LESION. THE REMAINDER OF THE CATHETER WAS REMOVED. THE PATIENT WENT TO SURGERY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM	CATHETER, CORONARY, ATHERECTOMY	MCX	BOSTON SCIENTIFIC - COSTA RICA	UNK509

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR		Required Intervention	CORSAIR BALLOON CATHETER\| DOC GUIDE WIRE\| BMW GUIDE WIRE