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Model Number M00568510 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/27/2019 |
Event Type
Injury
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Manufacturer Narrative
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(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.
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Event Description
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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.
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Manufacturer Narrative
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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.
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Event Description
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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.
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Manufacturer Narrative
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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.
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Event Description
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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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Search Alerts/Recalls
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