MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE JEJUNAL FEEDING TUBE; TUBE, FEEDING

Model Number UNK-P-TTP_-_JEJUNAL_-_ENTERAL_FEEDING

Device Problem Human-Device Interface Problem (2949)

Patient Problem Vomiting (2144)

Event Date 05/03/2020

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 complaint 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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that an endovive two-port through the peg jejunal tube was used for the purpose of administering medication for advanced stage parkinson's disease.The procedure date is unknown.According to the complainant, on (b)(6) 2020, the patient got caught on the bed which caused jejunal tube to come out of the patient.The patient's wife inserted the jejunal tube back in.Reportedly, the patient experienced vomiting.The physician was contacted and instructed to remove the jejunal tube due to patient vomiting.The peg tube was intact.Currently, patient is taking oral medication exact types are unknown.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

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.(device codes): problem code 2949 captures the reportable event of jejunal tube intentional/unintentional patient removal.(patient codes): patient code 2144 captures the reportable event of patient vomiting.(evaluation conclusion codes): the complainant indicated that the complaint 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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that an endovive two-port through the peg jejunal tube was used for the purpose of administering medication for advanced stage parkinson's disease.The procedure was performed on (b)(6) 2019.According to the complainant, on (b)(6), 2020, the patient got caught on the bed which caused jejunal tube to come out of the patient.The patient's wife inserted the jejunal tube back in.Reportedly, the patient experienced vomiting.The physician was contacted and instructed to remove the jejunal tube due to patient vomiting.The peg tube was intact.Currently, patient is also taking pantoprazole.There were no reported patient complications as a result of this event.

• Brand Name: ENDOVIVE JEJUNAL FEEDING TUBE
• Type of Device: TUBE, FEEDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10097771
• MDR Text Key: 193993962
• Report Number: 3005099803-2020-02089
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-P-TTP_-_JEJUNAL_-_ENTERAL_FEEDING
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DUODOPA; DUODOPA; PANTOPRAZOLE
• Patient Age: 72 YR
• Patient Weight: 91