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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 24F 2.4CM; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
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BOSTON SCIENTIFIC CORPORATION ENDOVIVE OSB KIT PULL W/ENFIT 24F 2.4CM; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS Back to Search Results
Model Number M00509660
Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).If there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that an endovive one step button was used during a percutaneous endoscopic gastrostomy procedure on (b)(6) 2021.During the procedure, when one step button was introduced in the oral cavity with the insertion wire and was pulled out from the stoma, a severe resistance was felt, the connection part of the tube and sheath part was separated.The detached portion was retrieved using a snare.The procedure was completed with a new endovive one step button.There were no patient complications reported as a result of this event.It was reported that no incision was made from the body surface to inside the stomach.The instructions for use (ifu) state: with scalpel, make a 1.5cm incision at the selected site.A smaller incision may contribute to excessive resistance of the one-step button when exiting the skin.
 
Manufacturer Narrative
Block h6 (device codes): problem code a0501 captures the reportable event of one step button detached.Problem code a150205 captures the reportable event of one step button difficult to advance.Block h10: the c-flex tubing of the endovive one step button was returned.Visual analysis of the device revealed that the tube was broken at the distal section however the button was not deployed.In addition, the tubing presented procedural fluids that showed the broken area was narrowed.The reported complaint was confirmed.Based on the condition of the returned device, engineers determined that the failure modes were caused due to user error of not performing an incision.The resistance and difficulties that were encountered as the user was placing the device may have been caused by extra tension which may have ended up breaking the c-flex tubing.Boston scientific has determined the most probable cause of this complaint is failure to follow instructions.It is most likely that the problems traced to the user not following the manufacturer's instructions.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 one step button was used during a percutaneous endoscopic gastrostomy procedure on (b)(6) 2021.During the procedure, when one step button was introduced in the oral cavity with the insertion wire and was pulled out from the stoma, a severe resistance was felt, the connection part of the tube and sheath part was separated.The detached portion was retrieved using a snare.The procedure was completed with a new endovive one step button.There were no patient complications reported as a result of this event.It was reported that no incision was made from the body surface to inside the stomach.The instructions for use (ifu) state: with scalpel, make a 1.5cm incision at the selected site.A smaller incision may contribute to excessive resistance of the one-step button when exiting the skin.
 
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Brand Name
ENDOVIVE OSB KIT PULL W/ENFIT 24F 2.4CM
Type of Device
GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key12079133
MDR Text Key259654328
Report Number3005099803-2021-03056
Device Sequence Number1
Product Code PIF
Combination Product (y/n)Y
PMA/PMN Number
K161003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/23/2023
Device Model NumberM00509660
Device Catalogue Number57741
Device Lot Number0025507961
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2021
Date Manufacturer Received07/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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