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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 03/02/2023
Event Type  Injury  
Event Description
It was reported to boston scientific corporation that an endovive securi-t replacement bolster was used during a percutaneous endoscopic gastrostomy procedure performed on (b)(6) 2023.During the replacement procedure, the bolster was detached inside the patient.The bolster was retrieved through an endoscope.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.(device codes): device code a0501 captures the reportable event of internal bolster detached.
 
Manufacturer Narrative
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): imdrf device code a0501captures the reportable event of internal bolster detached.Block h10: an endovive securi-t replacement bolster was analyzed.Visual analysis of the device revealed that the feeding tube has the internal bolster detached.There are traces of adhesion in the distal end of the feeding tube and the device contains remnants of use.Therefore, the reported complaint is confirmed.Based on the condition of the returned device, engineers determined that the problem observed could be due to excessive stress, perhaps manipulation or the patient's anatomical conditions may have contributed to the separation.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.
 
Event Description
It was reported to boston scientific corporation that an endovive securi-t replacement bolster was used during a percutaneous endoscopic gastrostomy procedure performed on (b)(6) 2023.During the replacement procedure, the bolster was detached inside the patient.The bolster was retrieved through an endoscope.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 Key16639921
MDR Text Key312280523
Report Number3005099803-2023-01653
Device Sequence Number1
Product Code KNT
Combination Product (y/n)Y
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
Report Date 05/09/2023
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 NumberM00509161
Device Catalogue Number0916
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/08/2023
Initial Date FDA Received03/29/2023
Supplement Dates Manufacturer Received04/19/2023
Supplement Dates FDA Received05/09/2023
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 Outcome(s) Other;
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