FDA Adverse Event Malfunction Summary report: N

ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP

MDR report key: 3902731 · Received June 30, 2014

Report

Report Number: 3005099803-2014-02364
Event Type: Malfunction
Date Received: June 30, 2014
Report Date: June 9, 2014
Manufacturer: BOSTON SCIENTIFIC - SPENCER
Product Code: KNT
PMA / PMN Number: K081739
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SE
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. REPORTED EVENT OF JEJUNAL TUBE MIGRATION. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE TWO-PORT THROUGH THE PEG JEJUNAL TUBE WAS BEING USED FOR THE PURPOSE OF ADMINISTERING MEDICATION FOR ADVANCED STAGE PARKINSON¿S DISEASE. DATE OF JEJUNAL TUBE PLACEMENT IS UNKNOWN, HOWEVER, IT WAS REPORTED THAT THE JEJUNAL TUBE HAD BEEN IN PLACE FOR A YEAR. ACCORDING TO THE COMPLAINANT, THE JEJUNAL TUBE CAME OUT A FEW CENTIMETERS FROM THE PEG TUBE. THE PATIENT EASILY PLACED THE JEJUNAL TUBE BACK IN THE PEG TUBE. 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
379803	ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP	TUBES, GASTROINTESTINAL (AND ACCESSORIES)	KNT	BOSTON SCIENTIFIC - SPENCER	UNK443

Patients

Seq	Age	Sex	Outcome	Treatment
1	76 YR			DUODOPA