FDA Adverse Event Death Summary report: N

APEX OVER-THE-WIRE

MDR report key: 1832100 · Received September 13, 2010

Report

Report Number: 2134265-2010-03979
Event Type: Death
Date Received: September 13, 2010
Date of Event: August 19, 2010
Report Date: August 19, 2010
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: LOX
PMA / PMN Number: P860019
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, 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 MFR#:2134265-2010-03978. IT WAS REPORTED THAT DURING A CORONARY TREATMENT PROCEDURE, THE PATIENT EXPIRED. THE TARGET LESION WAS LOCATED AT A BIFURCATION OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN CANNULATED THE VESSEL AND THE REMAINDER OF THE LAD WASN'T SEEN ON ANGIOGRAPHY. A KINETIX GUIDEWIRE CROSSED THE LESION AND A 2.0X15MM APEX BALLOON WAS ADVANCED. HOWEVER, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION AND EXPIRED. PER THE PHYSICIAN, THE PATIENT'S DEATH WAS UNRELATED TO THE GUIDEWIRE AND BALLOON; ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	APEX OVER-THE-WIRE	CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS	LOX	BOSTON SCIENTIFIC - MAPLE GROVE	H7493895815200

Patients

Seq	Age	Sex	Outcome	Treatment
1	91 YR		Death	KINETIX GUIDEWIRE