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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 M00509171
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2022
Event Type  malfunction  
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.The procedure date was unknown.Post procedure, two to three days after placement, the staff raised the upper body of the patient and spontaneous removal of the device occurred due to intragastric pressure.The procedure was completed with a different 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.(b)(4).
 
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.The procedure date was unknown.Post procedure, two to three days after placement, the staff raised the upper body of the patient and spontaneous removal of the device occurred due to intragastric pressure.The procedure was complete with a different device.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h11: correction: block a2 (age at time of event) has been corrected.
 
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 h6 (device codes): device code a051201 captures the reportable event of peg tube dislodged or dislocated.Block h10: an endovive securi-t replacement bolster was returned.Visual analysis revealed that the silicon tube was in good condition and the bolster was attached.Therefore, the reported complaint was not confirmed.Based on the condition of the returned device, engineers determined that the device contains remnant of use; perhaps the manipulation, or patient's anatomical conditions could have contributed to this event, however, there is no objective evidence to determine that the reported event occurs due to a device issue.Boston scientific has determined the most probable cause of this complaint is no problem detected.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.Block h11: correction: block a2 (age at time of event) has been corrected.
 
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.The procedure date was unknown.Post procedure, two to three days after placement, the staff raised the upper body of the patient and spontaneous removal of the device occurred due to intragastric pressure.The procedure was completed with a different device.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
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key15970109
MDR Text Key308480591
Report Number3005099803-2022-07178
Device Sequence Number1
Product Code KNT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 01/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00509171
Device Catalogue Number0917
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/16/2022
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
Patient Age42 YR
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