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); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2020

Event Type  Injury  

Manufacturer Narrative

Initial reporter address: (b)(6).(b)(4).The device has been received for analysis.Upon 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 (b)(6) 2020.According to the complainant, during the procedure, as the one step button was passed through the patient, the catheter was torn and separated.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 e1 (initial reporter address 1): (b)(6).Block h6 (device codes): problem code 2907 captures the reportable event of one step button delivery system detached.H10: a visual examination of the device revealed that the button was not released.The c-flex tubing was broken, resulting in button delivery system separation.Therefore, the reported complaint was confirmed.It was noted the c-flex tubing was narrowed near the 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 the narrow section confirming that the component was stretched.Probably the c-flex tubing was broken/separated due to user technique, patient anatomy or other procedural factors such as the incision size, also force applied to pull the device during placement could have contributed to the event, stretching material found on the c-flex tubing suggests that the component was submitted to a tensile force.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.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 (peg) placement procedure (b)(6) 2020.According to the complainant, during the procedure, as the one step button was passed through the patient the catheter was torn and separated.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 october 14, 2020.One step button tube got broken near the button.Reportedly, the detached portion was retrieved.

• 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: 10695557
• MDR Text Key: 211860646
• Report Number: 3005099803-2020-04727
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2023
• Device Model Number: M00568520
• Device Catalogue Number: 6852
• Device Lot Number: 0025568201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other