FDA Adverse Event Malfunction Summary report: N

VERIFLEX¿

MDR report key: 2945720 · Received February 6, 2013

Report

Report Number: 2134265-2013-00370
Event Type: Malfunction
Date Received: February 6, 2013
Date of Event: January 8, 2013
Report Date: January 9, 2013
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: MAF
PMA / PMN Number: P040016
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS PULLED DISTALLY ON THE BALLOON RESULTING IN THE PROXIMAL EDGE OF THE STENT BEING POSITIONED AT 8MM DISTAL TO THE DISTAL EDGE OF THE PROXIMAL MARKERBAND. AN EXAMINATION OF THE CRIMPED STENT FOUND THAT THE STENT STRUTS WERE MISALIGNED APPROXIMATELY 7-8MM PROXIMAL TO IT'S DISTAL EDGE. AN EXAMINATION OF THE BALLOON FOUND CLEAR EVIDENCE OF STENT CRIMP. THE BALLOON DOES NOT APPEAR TO HAVE BEEN SUBJECTED TO ANY POSITIVE PRESSURE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING THE PREPARATION FOR A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. A 5.0X20MM VERIFLEX STENT WAS BEING PREPPED FOR USE, HOWEVER, RESISTANCE WAS MET WHILE REMOVING THE SLEEVE AND STENT DAMAGE OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
50430	VERIFLEX¿	STENT, CORONARY	MAF	BOSTON SCIENTIFIC - GALWAY	H7493893420500	14044981

Patients

Seq	Age	Sex	Outcome	Treatment
1