ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP

Report

Report Number: 3005099803-2010-05181
Event Type: Injury
Date Received: December 21, 2010
Date of Event: November 18, 2010
Report Date: November 30, 2010
Manufacturer: BOSTON SCIENTIFIC - SPENCER
Product Code: KNT
PMA / PMN Number: K081739
Adverse Event: Yes
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. (B)(4) - J-TUBE EXCHANGE. (B)(4) - THE REPORTED EVENT OF PHYTOBEZOAR ON DISTAL LOOP OF J-TUBE. 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 A TWO PORT THROUGH THE PEG JEJUNAL FEEDING TUBE (J-TUBE) WAS BEING USED FOR THE PURPOSE OF ADMINISTERING MEDICATION FOR THE ADVANCED STAGE PARKINSON'S DISEASE. THE J-TUBE WAS PLACED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2010, THE PATIENT PRESENTED WITH PAIN AND A PHYTOBEZOAR ON THE DISTAL LOOP OF THE J-TUBE. THE PHYTOBEZOAR WAS REMOVED BY MEANS OF AN ESOPHAGOGASTRODUODENOSCOPY. THE PROCEDURE WAS COMPLETED WITH A NEW TWO PORT THROUGH THE PEG JEJUNAL FEEDING TUBE (J-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
1	ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP	TUBES, GASTROINTESTINAL (AND ACCESSORIES)	KNT	BOSTON SCIENTIFIC - SPENCER	UNK443

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other	DUODOPA