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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE REPL BUTTON K W/ENFIT 18F 2.4CM; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
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BOSTON SCIENTIFIC CORPORATION ENDOVIVE REPL BUTTON K W/ENFIT 18F 2.4CM; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS Back to Search Results
Model Number M00509800
Device Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2023
Event Type  malfunction  
Manufacturer Narrative
Date of event was approximated to 01feb2023 as no event date was reported.Impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.
 
Event Description
It was reported to boston scientific corporation that an endovive one step button was used during a gastrostomy replacement procedure.The procedure date is unknown.It was reported that upon checking the device, a hole was found at the tip of the bumper.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that an endovive one step button was used during a gastrostomy replacement procedure.The procedure date is unknown.It was reported that upon checking the device, a hole was found at the tip of the bumper.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.Additional information was received on april 03, 2023: it was reported that the patient was not sedated, and the problem was noticed during preparation, before sedation.
 
Manufacturer Narrative
Block b3 (date of event): date of event was approximated to (b)(6) 2023 as no event date was reported.Block h6 (impact codes): impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: one endovive one step button kit was returned.During product analysis was observed that the bolster was punctured at the dome.Therefore, the reported complaint is confirmed.Based on the condition of the returned device, engineers determined that the problem observed could be due to the manipulation and/or some technique applied during the preparation of the device could have contributed to the reported problem.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 the event which led to the reported event.
 
Event Description
It was reported to boston scientific corporation that an endovive one step button was used during a gastrostomy replacement procedure.The procedure date is unknown.It was reported that upon checking the device, a hole was found at the tip of the bumper.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.Additional information was received on april 03, 2023: it was reported that the patient was not sedated, and the problem was noticed during preparation, before sedation.
 
Manufacturer Narrative
Block b3 (date of event): date of event was approximated to (b)(6) 2023 as no event date was reported.Block h10: one endovive one step button kit was returned.During product analysis was observed that the bolster was punctured at the dome.Therefore, the reported complaint is confirmed.Based on the condition of the returned device, engineers determined that the problem observed could be due to the manipulation and/or some technique applied during the preparation of the device could have contributed to the reported problem.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 the event which led to the reported event.Block h6 impact code has been updated based on additional information received on 03apr2023.
 
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Brand Name
ENDOVIVE REPL BUTTON K W/ENFIT 18F 2.4CM
Type of Device
GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
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 Key16405970
MDR Text Key310086562
Report Number3005099803-2023-00867
Device Sequence Number1
Product Code PIF
Combination Product (y/n)Y
Reporter Country CodeJA
PMA/PMN Number
K161003
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 05/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00509800
Device Catalogue Number57776
Device Lot Number0029831657
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/03/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/25/2022
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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