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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 3.4CM; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
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BOSTON SCIENTIFIC CORPORATION ENDOVIVE REPL BUTTON K W/ENFIT 18F 3.4CM; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS Back to Search Results
Model Number M00509810
Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that an endovive replacement button was used during a percutaneous endoscopic gastrostomy (peg) replacement procedure.The procedure date is unknown.During procedure, the internal bolster detached outside patient when stretched with an obturator.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): date of event was approximated to (b)(6) 2022 as no event date was reported.(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.
 
Manufacturer Narrative
Block b3 (date of event): date of event was approximated to 01apr2022 as no event date was reported.Block h6 (device code): device problem code a0501 captures the reportable event of internal bolster detached.Block h10: the returned endovive low profile replacement button kit was analyzed.During product analysis, the button dome returned pierced by the rod.There is no evidence of internal bolster detachment.Therefore, the reported complaint is not confirmed.Based on the condition of the returned device, engineers determined that the problem observed is most likely due to the technique used by the physician in conjunction with an excess of force applied with the obturator rod punctured the button dome.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 replacement button was used during a percutaneous endoscopic gastrostomy (peg) replacement procedure.The procedure date is unknown.During procedure, the internal bolster detached outside patient when stretched with an obturator.The procedure was completed with a different device.There were no patient complications reported as a result of this event.(b)(6) additional information received on (b)(6), 2022: the procedure was completed with a different size from a non scientific device.
 
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Brand Name
ENDOVIVE REPL BUTTON K W/ENFIT 18F 3.4CM
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 Key14294624
MDR Text Key290975287
Report Number3005099803-2022-02444
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
Report Date 06/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00509810
Device Catalogue Number57776
Device Lot Number0027990542
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/12/2021
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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