APEX BALLOON CATHETER

Report

Report Number: 2134265-2010-05621
Event Type: Injury
Date Received: December 13, 2010
Date of Event: June 12, 2009
Report Date: November 17, 2010
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: LOX
PMA / PMN Number: P860019
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). 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

(B)(4) CLINICAL TRIAL. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE A DISSECTION OCCURRED. THE INDEX PROCEDURE TREATED TWO LESIONS. LESION ONE WAS LOCATED IN THE 70% STENOSED PROXIMAL LAD (LEFT ANTERIOR DESCENDING) AND MEASURED 3.5X14MM. LESION ONE WAS TREATED WITH PREDILATION AND PLACEMENT OF A 3.5X18/20MM PLATINUM STUDY STENT WITH 0% RESIDUAL STENOSIS. LESION TWO WAS LOCATED IN THE 70% STENOSED 3RD OBTUSE MARGINAL AND MEASURED 3.0X14MM. LESION TWO WAS TREATED WITH PREDILATION USING AN APEX BALLOON AND PLACEMENT OF A 3.0X18/20MM PLATINUM STUDY STENT RESULTING IN 0% RESIDUAL STENOSIS. THE CORE LAB REPORT INDICATED THAT A TYPE C DISSECTION WAS NOTED AFTER PREDILATION AND WAS TREATED WITH THE STUDY STENT. THE PATIENT WAS DISCHARGED ONE DAY POST PROCEDURE ON ASPIRIN AND CLOPIDOGREL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	APEX BALLOON CATHETER	CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS	LOX	BOSTON SCIENTIFIC - MAPLE GROVE	UNK21

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR		Required Intervention