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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE OSB KIT PULL W/ENFIT 18F 3.4CM; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
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BOSTON SCIENTIFIC CORPORATION ENDOVIVE OSB KIT PULL W/ENFIT 18F 3.4CM; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS Back to Search Results
Model Number M00509780
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 12/23/2022
Event Type  Injury  
Event Description
It was reported to boston scientific corporation that an endovive low profile replacement button was used during a gastrostomy replacement procedure on (b)(6) 2022.During the procedure, when replacing the endovive one step button pull device, which was already placed in the abdomen, the bumper was separated when the device was stretched using an obturator.Since the bumper was separated, it was pulled out and removed as it was.The procedure was completed with a new endovive low profile replacement button.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
(b)(6).
 
Manufacturer Narrative
Block h6 (device codes): device code a0501captures the reportable event of internal bolster detached.Block h10: the returned endovive low profile replacement button was analyzed.Upon visual assessment, it was observed that the button dome contains remnants of use.Microscope inspection observed that the button dome was ruptured by rod.The initial reported event of internal bolster was not confirmed.Based on the condition of the returned device, engineers determined that the problem observed could be due to the manipulation, technique used, or patients' anatomical conditions.An excess of force could have been applied resulting in the button dome being ruptured.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 low profile replacement button was used during a gastrostomy replacement procedure on (b)(6) 2022.During the procedure, when replacing the endovive one step button pull device, which was already placed in the abdomen, the bumper was separated when the device was stretched using an obturator.Since the bumper was separated, it was pulled out and removed as it was.The procedure was completed with a new endovive low profile replacement button.There were no patient complications reported as a result of this event.
 
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Brand Name
ENDOVIVE OSB KIT PULL 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 Key16225295
MDR Text Key307916611
Report Number3005099803-2023-00077
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 03/06/2023
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 NumberM00509780
Device Catalogue Number57741
Device Lot Number0027875010
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/26/2022
Initial Date FDA Received01/23/2023
Supplement Dates Manufacturer Received02/13/2023
Supplement Dates FDA Received03/06/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/13/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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