FDA Adverse Event Malfunction Summary report: N

EMERGE¿

MDR report key: 3011592 · Received March 19, 2013

Report

Report Number: 2134265-2013-01762
Event Type: Malfunction
Date Received: March 19, 2013
Date of Event: January 17, 2013
Report Date: February 28, 2013
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: LOX
PMA / PMN Number: K113220
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE RETURNED TO 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

(B)(4). SAME CASE AS: 2134265-2013-01766. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A WATERMELON SEEDING OF THE BALLOON CATHETER OCCURRED. THE PATIENT PRESENTED WITH CLASS 2 STABLE ANGINA. THE 70% STENOSED DE NOVO LESION WAS LOCATED IN THE SAPHENOUS VEIN GRAFT TO 1ST DIAGONAL ARTERY WITH A REFERENCE VESSEL DIAMETER OF 4MM AND A LESION LENGTH OF 15MM. BALLOON ANGIOPLASTY WAS PERFORMED IN THE TARGET LESION WITH 3.00 X 12 MM AND 2.50 X 12 MM EMERGE BALLOON CATHETERS. WATERMELON SEEDING OCCURRED WITH BOTH BALLOONS. IT WAS ALSO REPORTED THAT A 4.00 MM X 16 MM PROMUS ELEMENT PLUS STENT WAS DEPLOYED IN THE TARGET LESION, RESULTING IN 0% RESIDUAL STENOSIS. NO COMPLICATIONS WERE NOTED AND THE PATIENT WAS DISCHARGED ON THE FOLLOWING DAY ON ASPIRIN AND PRASUGREL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
114008	EMERGE¿	CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS	LOX	BOSTON SCIENTIFIC - MAPLE GROVE	UNK731

Patients

Seq	Age	Sex	Outcome	Treatment
1	71 YR