FDA Adverse Event Death Summary report: N

ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

MDR report key: 2882644 · Received December 20, 2012

Report

Report Number: 2134265-2012-08161
Event Type: Death
Date Received: December 20, 2012
Report Date: December 4, 2012
Manufacturer: BOSTON SCIENTIFIC - CORK
Product Code: MCX
PMA / PMN Number: P900056
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MANUFACTURER: 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

IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE PATIENT EXPIRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX (LCX) ARTERY TO THE DIAGONAL. THE PHYSICIAN ADVANCED A ROTALINK BURR TO THE LCX AND PERFORMED ABLATION. ANGIO WAS PERFORMED AND AN UNSPECIFIED STENT WAS PLACED. ATHERECTOMY WAS BEING PERFORMED IN THE DIAGONAL WHEN THE PATIENT CODED AND LATER EXPIRED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM	CATHETER, CORONARY, ATHERECTOMY	MCX	BOSTON SCIENTIFIC - CORK	UNK553

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death