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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE SECURI-T; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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BOSTON SCIENTIFIC CORPORATION ENDOVIVE SECURI-T; TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Model Number M00568151
Device Problems Detachment of Device or Device Component (2907); Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/16/2021
Event Type  malfunction  
Manufacturer Narrative
This event was reported by the distributor.The health care facility is: (b)(6).(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 securi-t replacement bolster was used during a percutaneous endoscopic gastrostomy replacement procedure on (b)(6) 2021.Post procedure, on (b)(6) 2021, the internal bolster detached inside the stomach.As per ct scan, the detached portion was in the small intestines and could not be retrieved.Observation was done and on (b)(6) 2021, it was excreted via stool.A new endovive securi-t replacement bolster was placed.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block e1: this event was reported by the distributor.The health care facility is: (b)(6).Block h6 (device codes): device problem code a0501 captures the reportable event of internal bolster detached.Device problem code a010402 captures the reportable event of internal bolster migration.Block h10: an endovive securi t replacement bolster was returned.The internal bolster was detached.Dimensional inspection confirmed that the device measurements were within specifications.Microscope inspection revealed that the internal bolster was once attached showing remains of the internal bolster on the tube.Therefore, the reported complaint is confirmed.Based on the condition of the returned device, engineers determined that the most possible cause of the detachment may be related to some technique performed during the insertion that may have affected the device and during the time it was placed anatomical factors could have contributed then it may lead to the detachment inside the body after the procedure.Once the bolster was detached, it is most likely that the device ended migrating.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.It is most likely that the adverse event occurred during the procedure and the device had no influence on event which led to the reported event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
 
Event Description
It was reported to boston scientific corporation that an endovive securi-t replacement bolster was used during a percutaneous endoscopic gastrostomy replacement procedure on (b)(6) 2021.Post procedure, on (b)(6) 2021, the internal bolster detached inside the stomach.As per ct scan, the detached portion was in the small intestines and could not be retrieved.Observation was done and on (b)(6) 2021, it was excreted via stool.A new endovive securi-t replacement bolster was placed.There were no patient complications reported as a result of this event.
 
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Brand Name
ENDOVIVE SECURI-T
Type of Device
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
carole morley morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key12814484
MDR Text Key281671337
Report Number3005099803-2021-05932
Device Sequence Number1
Product Code KNT
Combination Product (y/n)Y
Reporter Country CodeJA
PMA/PMN Number
K961345
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/12/2024
Device Model NumberM00568151
Device Catalogue Number6815
Device Lot Number0026838824
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received12/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/12/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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