MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE ONE STEP BUTTON; TUBE, GASTRO-ENTEROSTOMY

Model Number M00568520

Device Problems Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).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 mdr 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 (b)(6) 2020.According to the complainant, during the procedure, when one step button was pulled from the oral cavity into the stomach, the button came out of the sheath earlier and was dislodged.Reportedly, the procedure was cancelled and rescheduled on (b)(6) 2020 using a different device.There were no patient complications reported as a result of this event.

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 (b)(6) 2020.According to the complainant, during the procedure, when one step button was pulled from the oral cavity into the stomach, the button came out of the sheath earlier and was dislodged.Reportedly, the procedure was cancelled and rescheduled on (b)(6), 2020 using a different device.There were no patient complications reported as a result of this event.Additional information received on (b)(6), 2020: the internal bolster detached portion was retrieved using forceps.

Manufacturer Narrative

Block h6 (device codes): problem code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Problem code 2907 captures the reportable event of osb came out of the sheath earlier.Block h10: a visual examination of the device revealed that blue pull wire, percutaneous stoma measuring device and the one step button assembly were returned for analysis.The button was not released.The c-flex tubing was broken resulting in button separation.In addition, the c-flex tubing was narrowed near broken area indicating stretching of material due to tensile force and the broken area was irregular.The outer diameter of the c-flex tubing was measured in some points of the device, the outer diameter was found out of specification in a narrow section confirming that the component was stretched.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 that the component was submitted to tensile force.Based on the information available and the analysis performed, the investigation conclusion code for the reported event 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.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed, and from the information available this device was used per the directions for use (dfu).

Manufacturer Narrative

Correction: b5 block h6 (device codes): problem code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Problem code 2907 captures the reportable event of osb came out of the sheath earlier.Block h10: a visual examination of the device revealed that blue pull wire, percutaneous stoma measuring device and the one step button assembly were returned for analysis.The button was not released.The c-flex tubing was broken resulting in button separation.In addition, the c-flex tubing was narrowed near broken area indicating stretching of material due to tensile force and the broken area was irregular.The outer diameter of the c-flex tubing was measured in some points of the device, the outer diameter was found out of specification in a narrow section confirming that the component was stretched.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 that the component was submitted to tensile force.Based on the information available and the analysis performed, the investigation conclusion code for the reported event 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.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed, and from the information available this device was used per the directions for use (dfu).

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 (b)(6)2020.According to the complainant, during the procedure, when one step button was pulled from the oral cavity into the stomach, the button came out of the sheath earlier and was dislodged.Reportedly, the procedure was cancelled and rescheduled on (b)(6), 2020 using a different device.There were no patient complications reported as a result of this event.Additional information received on (b)(6), 2020: the internal bolster detached portion was retrieved using forceps.

• 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 Key: 10369054
• MDR Text Key: 201869653
• Report Number: 3005099803-2020-03140
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 08714729149231
• UDI-Public: 08714729149231
• Combination Product (y/n): N
• PMA/PMN Number: K910584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2023
• Device Model Number: M00568520
• Device Catalogue Number: 6852
• Device Lot Number: 0025592984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Date Manufacturer Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other