FDA Adverse Event Malfunction Summary report: N

EMERGE?

MDR report key: 3832902 · Received May 27, 2014

Report

Report Number: 2134265-2014-03176
Event Type: Malfunction
Date Received: May 27, 2014
Date of Event: April 26, 2014
Report Date: April 26, 2014
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: LOX
PMA / PMN Number: K113220
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NL
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. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. IT WAS REPORTED THAT THE DEVICE WAS INFLATED TO 20ATM, WHICH WAS ABOVE THE RATED BURST PRESSURE OF 14ATM FOR THE COMPLAINT DEVICE. THE DIRECTIONS FOR USE STATES; "DO NOT EXCEED THE RATED BALLOON BURST PRESSURE." THE MOST PROBABLE ROOT CAUSE IS CONSIDERED USER RELATED. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A CORONARY ARTERY TREATMENT PROCEDURE, BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE OSTIUM OF RIGHT CORONARY ARTERY (RCA) WITH 95% STENOSIS AND WAS 18MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4MM. A 2.00X20MM EMERGE BALLOON CATHETER WAS USED TO PRE-DILATE THE LESION AT 20ATM. THE BALLOON RUPTURED AND WAS EASILY RETRACTED THROUGH THE GUIDE CATHETER. THEN THE LESION WAS TREATED WITH A 4.0X22MM DRUG-ELUTING STENT WHICH RECOILED THE OSTIUM. ANOTHER 4.0X12MM DRUG-ELUTING STENT WAS DEPLOYED. THE EVENT WAS RESOLVED. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
311720	EMERGE?	CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS	LOX	BOSTON SCIENTIFIC - MAPLE GROVE	H7493919320200	16771228

Patients

Seq	Age	Sex	Outcome	Treatment
1	76 YR