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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 M00509161
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2022
Event Type  Injury  
Event Description
It was reported to boston scientific corporation that an endovive securi-t replacement bolster was used during a gastrostomy replacement procedure.The procedure date was unknown.When attempting to remove the placed device the bumper was left inside the patient.It was retrieved and the procedure was completed with another endovive securi-t device.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Date of event was approximated to (b)(6) 2022 as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.The complainant was unable to provide physician information, the reported healthcare facility is: fukuda general hospital, +011(810)728475752, 1-18-11 nagisa-nishi, hirakata city osaka, japan, 5731178.
 
Manufacturer Narrative
Block b3 (date of event): date of event was approximated to 11/01/2022 as no event date was reported.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: the complainant was unable to provide physician information, the reported healthcare facility is: (b)(6) hospital.(b)(6).Block h6 (device codes): device code a0501captures the reportable event of internal bolster detached.Block h10: the returned endovive securi-t replacement bolster was analyzed.Upon visual assessment, it was observed that silicone tube of the bolster was detached.Therefore, the complaint is confirmed.Based on the condition of the returned device, engineers determined that it is possible that the device may have faced an excess of applied force; perhaps the manipulation, or patient's anatomical conditions could have contributed to this event.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.
 
Event Description
It was reported to boston scientific corporation that an endovive securi-t replacement bolster was used during a gastrostomy replacement procedure.The procedure date was unknown.When attempting to remove the placed device the bumper was left inside the patient.It was retrieved and the procedure was completed with another endovive securi-t device.There were no patient complications reported as a result of this event.The device has not been returned.
 
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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
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key15998606
MDR Text Key305679120
Report Number3005099803-2022-07482
Device Sequence Number1
Product Code KNT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberM00509161
Device Catalogue Number0916
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received12/20/2022
Was Device Evaluated by Manufacturer? Yes
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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