FDA Adverse Event Death Summary report: N

ROTALINK¿ PLUS

MDR report key: 2870325 · Received December 12, 2012

Report

Report Number: 2134265-2012-07566
Event Type: Death
Date Received: December 12, 2012
Date of Event: October 9, 2012
Report Date: November 14, 2012
Manufacturer: BOSTON SCIENTIFIC - CORK
Product Code: MCX
PMA / PMN Number: P900056
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WI, 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

SAME CASE AS MDR ID# 2134265-2012-07567. IT WAS REPORTED THAT DURING AN ABLATION TREATMENT PROCEDURE, VESSEL PERFORATION OCCURRED AND LATER EXPIRED. THE ANOMALOUS TARGET LESION WAS LOCATED IN AN ACUTE ANGLE (45-60 DEGREES) OF THE MID LEFT CIRCUMFLEX (LCX) ARTERY. THE PHYSICIAN WAS PERFORMING ABLATION USING A 1.25MM ROTALINK BURR OVER A ROTAWIRE WHEN A PERFORATION OCCURRED. WIRE POSITION WAS LOST AND THE PHYSICIAN WAS UNABLE TO RE-CROSS THE LESION WITH A DIFFERENT WIRE. THE PHYSICIAN THEN OCCLUDED THE PROXIMAL PORTION OF THE LCX WITH AN UNKNOWN BALLOON CATHETER TO STOP THE LEAK. THE PATIENT WAS STABLE WITH NO PAIN AND WAS SENT FOR OBSERVATION. LATER THAT DAY THE PATIENT STARTED HAVING PAIN AND WENT INTO CARDIAC ARREST. CPR WAS PERFORMED BUT THE PATIENT EXPIRED BEFORE GETTING TO THE LAB.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ROTALINK¿ PLUS	CATHETER, CORONARY, ATHERECTOMY	MCX	BOSTON SCIENTIFIC - CORK	H749236310020

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR		Death\| R