FDA Adverse Event Malfunction Summary report: N

CRE? WIREGUIDED

MDR report key: 3812411 · Received May 15, 2014

Report

Report Number: 3005099803-2014-02009
Event Type: Malfunction
Date Received: May 15, 2014
Date of Event: April 17, 2014
Report Date: April 23, 2014
Manufacturer: BOSTON SCIENTIFIC - CORK
Product Code: KNQ
PMA / PMN Number: K110833
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

REPORTED EVENT OF EXIT MARKER DETACHED. THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. IT WAS REPORTED THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED BALLOON WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE NEXT ERCP PROCEDURE, THEY WERE USING THE SAME ENDOSCOPE; HOWEVER, THE DEVICES COULD NOT BE ADVANCED THROUGH THE SCOPE. THEY FOUND THAT THE EXIT MARKER OF THE CRE BALLOON USED IN THE PREVIOUS PROCEDURE HAD DETACHED AND WAS STUCK IN THE SCOPE WORKING CHANNEL, BLOCKING THE DEVICES. THE FRAGMENT WAS REMOVED FROM THE SCOPE WITHOUT A PROBLEM. ATTEMPTS TO OBTAIN FURTHER INFORMATION ABOUT THE PROCEDURES HAVE BEEN MADE, HOWEVER NO INFORMATION WAS AVAILABLE. IF FURTHER INFORMATION IS OBTAINED, A SUPPLEMENTAL MDR WILL BE FILED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
291974	CRE? WIREGUIDED	DILATOR, ESOPHAGEAL	KNQ	BOSTON SCIENTIFIC - CORK	M00558450

Patients

Seq	Age	Sex	Outcome	Treatment
1