MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number UNK443

Device Problem Human-Device Interface Problem (2949)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/19/2018

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device was disposed and 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.

Event Description

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.The procedure date is unknown.According to the complainant, the duodopa pump fell down from the patient while he was taking a semi shower in the bathroom and the intestinal tube slipped out from 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.

Manufacturer Narrative

The complainant reported that the device was not expired.The name of the neurologist is d walaa elsayed.

Event Description

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.The procedure date is unknown.According to the complainant, the duodopa pump fell down from the patient while he was taking a semi shower in the bathroom and the intestinal tube slipped out from 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.Additional information received on march 1, 2018.The procedure date is (b)(6) 2017.It was on (b)(6) 2018 when the intestinal tube slipped out from the peg tube.The jejunal tube was reinserted on (b)(6) 2018 by a gastroenterologist through endoscopy.On the same date, the duodopa pump was reconnected.The patient stayed at the hospital for observation until his condition became stable.The patient was discharged and was prescribed with suitable dose of medications.Currently, the patient is doing well.

• Brand Name: ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7282157
• MDR Text Key: 100653730
• Report Number: 3005099803-2018-00508
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K081739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UNK443
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DUODOPA; REMERON; RIVOLRIL; SEROQUEL; SINEMET; STALVO
• Patient Age: 53 YR
• Patient Weight: 65