FDA Adverse Event Malfunction Summary report: N

CRE? WIREGUIDED DASE

MDR report key: 3941603 · Received July 17, 2014

Report

Report Number: 3005099803-2014-02559
Event Type: Malfunction
Date Received: July 17, 2014
Report Date: June 26, 2014
Manufacturer: BOSTON SCIENTIFIC - CORK
Product Code: FGE
PMA / PMN Number: K112994
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

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. REPORTED EVENT OF DISTAL TIP DETACHED/MISSING. 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 BALLOON WAS USED DURING AN ESOPHAGEAL DILATION PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS DIFFICULT TO REMOVE FROM THE SCOPE AND FORCE WAS NEEDED TO REMOVE THE BALLOON. ONCE REMOVED, BIOPSY FORCEPS WERE PUSHED DOWN THE ENDOSCOPE AND A ¿WHITE PIECE OF PLASTIC ABOUT AN INCH LONG OR MORE" WAS PUSHED OUT OF THE SCOPE. IT IS UNKNOWN WHETHER THE PIECE WAS RETRIEVED OR NOT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
419563	CRE? WIREGUIDED DASE	CATHETER, BILIARY, DIAGNOSTIC	FGE	BOSTON SCIENTIFIC - CORK	UNK786

Patients

Seq	Age	Sex	Outcome	Treatment
1