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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE ONE STEP BUTTON; TUBE, GASTRO-ENTEROSTOMY
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BOSTON SCIENTIFIC CORPORATION ENDOVIVE ONE STEP BUTTON; TUBE, GASTRO-ENTEROSTOMY Back to Search Results
Model Number M00568510
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/27/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, 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 (peg) placement procedure performed on (b)(6) 2019.According to the complainant, during the procedure, when the device was being pulled inside the body, severe resistance was felt.Force was applied slowly; however, the sheath with the button inside detached from the tube.The procedure was completed with a new endovive one step button.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6 (device codes): problem code 2907 captures the reportable event of one step button delivery system detached.Block h10: visual examination of the returned device revealed that the sheath, suture, red strip and button were intact.The c-flex tubing was broken approximately 1.4cm of the tubing remained on the distal end of the connector.The c-flex tubing is narrowed near broken area indicating stretching of material due to tensile force and the broken area was irregular.The outer diameter of c-flex was also measured and it was found within specification.The complaint was consistent with the reported event of detached one step button delivery system.It is most likely that procedural and anatomical factors encountered during the procedure could have affected the device performance and its integrity.Probably the c-flex tubing was broken/separated due to user technique, patient anatomy or other procedural factors such the incision size, also force applied to pull the device during placement could have contributed with the event, stretching material found on the c-flex tubing suggests tensile force.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications, however there is no control how the devices and handled/manipulated in the field.Based on the information available and the analysis performed, the investigation conclusion code for the complaint will be documented as adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.The dhr review was performed and no anomalies were observed, the review confirmed that the accepted device met all manufacturing specifications.
 
Event Description
It was reported to boston scientific corporation that an endovive one step button was used during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2019.According to the complainant, during the procedure, when the device was being pulled inside the body, severe resistance was felt.Force was applied slowly; however, the sheath with the button inside detached from the tube.The procedure was completed with a new endovive one step button.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Additional information: block b5.Block h6 (device codes): problem code 2907 captures the reportable event of one step button delivery system detached.Visual examination of the returned device revealed that the sheath, suture, red strip and button were intact.The c-flex tubing was broken approximately 1.4cm of the tubing remained on the distal end of the connector.The c-flex tubing is narrowed near broken area indicating stretching of material due to tensile force and the broken area was irregular.The outer diameter of c-flex was also measured and it was found within specification.The complaint was consistent with the reported event of detached one step button delivery system.It is most likely that procedural and anatomical factors encountered during the procedure could have affected the device performance and its integrity.Probably the c-flex tubing was broken/separated due to user technique, patient anatomy or other procedural factors such the incision size, also force applied to pull the device during placement could have contributed with the event, stretching material found on the c-flex tubing suggests tensile force.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications, however there is no control how the devices and handled/manipulated in the field.Based on the information available and the analysis performed, the investigation conclusion code for the complaint will be documented as adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.The dhr review was performed and no anomalies were observed, the review confirmed that the accepted device met all manufacturing specifications.
 
Event Description
It was reported to boston scientific corporation that an endovive one step button was used during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2019.According to the complainant, during the procedure, when the device was being pulled inside the body, severe resistance was felt.Force was applied slowly; however, the sheath with the button inside detached from the tube.The procedure was completed with a new endovive one step button.There were no patient complications reported as a result of this event.Additional information received on (b)(6) 2019: reportedly, the sheath with the button inside detached inside the patient.The detached piece was retrieved, however, it was unknown what device was used to retrieve the detached piece.
 
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Brand Name
ENDOVIVE ONE STEP BUTTON
Type of Device
TUBE, GASTRO-ENTEROSTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8715975
MDR Text Key148534907
Report Number3005099803-2019-03174
Device Sequence Number1
Product Code KGC
UDI-Device Identifier08714729151081
UDI-Public08714729151081
Combination Product (y/n)N
PMA/PMN Number
K910584
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 10/01/2019
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 Expiration Date02/07/2022
Device Model NumberM00568510
Device Catalogue Number6851
Device Lot Number0023383519
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2019
Initial Date Manufacturer Received 05/28/2019
Initial Date FDA Received06/20/2019
Supplement Dates Manufacturer Received08/23/2019
09/07/2019
Supplement Dates FDA Received09/06/2019
10/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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