FDA Adverse Event Malfunction Summary report: N

CRE¿ WIREGUIDED

MDR report key: 2899572 · Received January 7, 2013

Report

Report Number: 3005099803-2013-00003
Event Type: Malfunction
Date Received: January 7, 2013
Report Date: December 19, 2012
Manufacturer: BOSTON SCIENTIFIC - CORK
Product Code: KNQ
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

IT WAS REPORTED THE PATIENT IS OVER 18 YEARS. THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. (B)(4) FOR THE REPORTED EVENT OF DEFLATION FAILED. THE 510K NUMBER IS K112994. 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 ON (B)(6) 2012 THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING A DILATATION PROCEDURE. ACCORDING TO THE COMPLAINT, WHEN THE PROCEDURE WAS COMPLETED WITH THIS BALLOON, THE PHYSICIAN ATTEMPTED TO DEFLATE THE BALLOON; HOWEVER ALL THE INFLATION MEDIUM WAS UNABLE TO BE REMOVED. HE WAS ABLE TO PULL THE CATHETER INTO THE ENDOSCOPE, BUT THE BALLOON PORTION OF THE DEVICE WOULD NOT FIT. THE DEVICE HAD TO BE REMOVED WITH THE ENDOSCOPE AND THE DISTAL TIP WAS CUT TO REMOVE THE BALLOON FROM THE SCOPE. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
8156	CRE¿ WIREGUIDED	BALLOON DILATOR	KNQ	BOSTON SCIENTIFIC - CORK	M00558700

Patients

Seq	Age	Sex	Outcome	Treatment
1