MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER ENDOVIVE¿ JEJUNAL FEEDING TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number M00566380

Device Problem Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2016

Event Type  Injury  

Manufacturer Narrative

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

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.According to the complainant, on (b)(6) 2016 at 10:20 am, the patient's partner reported that the jejunal tube had an occlusion.The clamps were open, flushing with water and air was unable to re-establish tube access.The pump was connected to the outer tube.During a home visit, the jejunal tube was cleared by flushing several times with a 10cc syringe and connected back to the pump.At 6:59pm, the pump gave a high pressure alarm.Flushing was difficult and the partner was advised to flush the jejunal tube with cola; however, the jejunal tube could not be cleared.During a second home visit, the clamps were removed and the jejunal tube was pulled back.A kink on the tube was removed and the issue was rectified.The device remains in use.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.

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.According to the complainant, on (b)(6) 2016 at 10:20 am, the patient's partner reported that the jejunal tube had an occlusion.The clamps were open, flushing with water and air was unable to re-establish tube access.The pump was connected to the outer tube.During a home visit, the jejunal tube was cleared by flushing several times with a 10cc syringe and connected back to the pump.At 6:59pm, the pump gave a high pressure alarm.Flushing was difficult and the partner was advised to flush the jejunal tube with cola; however, the jejunal tube could not be cleared.During a second home visit, the clamps were removed and the jejunal tube was pulled back.A kink on the tube was removed and the issue was rectified.The device remains in use.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 as of april 5, 2016.On (b)(6) 2016, the patient's partner called as the pump, which was connected to the outer tube, gave a high pressure alarm.Reportedly, there was no problem noticed during the flushing in the morning; however, air was noticed coming back.Patient received a home visit and the accessibility of the tube was tested using water and sparkling water without sodium bicarbonate.The accessibility was still very difficult as it would take 5-10 minutes for it to completely flush.In addition, the inner tube was loosened and pushed back but still without changes.An abdominal x-ray was scheduled for monday, as it was suspected that there was a kink in the inner tube.A new jejunal tube was placed.

• Brand Name: ENDOVIVE¿ JEJUNAL FEEDING TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5545262
• MDR Text Key: 41794348
• Report Number: 3005099803-2016-00846
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: K081739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00566380
• Device Catalogue Number: 6638
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 04/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR