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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE JEJUNAL FEEDING TUBE; TUBE, FEEDING
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BOSTON SCIENTIFIC CORPORATION ENDOVIVE JEJUNAL FEEDING TUBE; TUBE, FEEDING Back to Search Results
Model Number M00566340
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2021
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.However, the complainant reported that the device was not expired.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that an endovive three-port through the peg jejunal tube was being used during a gastrostomy replacement procedure performed on (b)(6) 2021.On (b)(6) 2021, post-procedure and before discharge, the nutrients could not be injected into the feeding tube.An endoscope was used to see there was a bend in the feeding tube.The physician was able to unbend the jejunal tube and the flow returned to normal.However, the physician decided the feeding tube needed to be replaced with a new endovive three-port through the peg jejunal tube.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.Block h6 (device codes): problem code a0406 captures the reportable event of feeding tube kinked.Block h10: the returned endovive jejunal feeding tube was analyzed, and a visual evaluation noted that the tube was kinked/bent approximately at 6cm from the distal end.Additionally, the tube was blackened in some locations.No other problems with the device were noted.The reported event of feeding tube kinked was confirmed.The condition of the tubing which was blackened in some locations could have been due to the time it was in place within the patient and due to administration of nutrients through the device.It was mentioned that kinking is a possible complication of ttp j-tubes and it is included within the adverse events section of the ifu, therefore the investigation conclusion code for the reported complaint will be documented as known inherent risk of device since reported adverse event known and documented in the labeling (including both short or long term known complications or adverse reactions.) a review of the manufacturing documentation for this device was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a dhr history review on the most probable lots did not identify any anomalies or deviations within manufacturing/service processes that could have contributed to the event.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
 
Event Description
It was reported to boston scientific corporation that an endovive three-port through the peg jejunal tube was being used during a gastrostomy replacement procedure performed on (b)(6) 2021.On (b)(6) 2021, post-procedure and before discharge, the nutrients could not be injected into the feeding tube.An endoscope was used to see there was a bend in the feeding tube.The physician was able to unbend the jejunal tube and the flow returned to normal.However, the physician decided the feeding tube needed to be replaced with a new endovive three-port through the peg jejunal tube.There were no patient complications reported as a result of this event.
 
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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 Key11409006
MDR Text Key234615808
Report Number3005099803-2021-00842
Device Sequence Number1
Product Code KNT
UDI-Device Identifier08714729789666
UDI-Public08714729789666
Combination Product (y/n)N
PMA/PMN Number
K091340
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00566340
Device Catalogue Number6634
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2021
Date Manufacturer Received04/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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