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

Model Number M00568470

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2020

Event Type  malfunction  

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) 2020. According to the complainant, during the procedure, when one step button loop wire was pulled, the tip separated. The device was removed and 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 analysis of the device revealed that one step button assembly was returned for analysis. The button was not release and dilating tip detached from the tubing. The reported complaint was confirmed. In addition, the c-flex tubing 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 separated due to user technique, patient anatomy or other procedural factors such the incision size, the force applied to pull the device during placement could have contributed with the event, stretching material on the c-flex tubing suggests that the component was submitted to tensile force during its use. Based on all gathered information and the analysis performed to the returned product, it was concluded that the investigation conclusion code of this event is 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 performed on (b)(6) 2020. According to the complainant, during the procedure, when one step button loop wire was pulled, the tip separated. The device was removed and procedure was completed with a new endovive one step button. There were no patient complications reported as a result of this event.

• Brand Name: ENDOVIVE ONE STEP BUTTON
• Type of Device: TUBE, GASTRO-ENTEROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10829124
• Report Number: 3005099803-2020-05300
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 08714729149217
• UDI-Public: 08714729149217
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K910584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/01/2022
• Device Model Number: M00568470
• Device Catalogue Number: 6847
• Device Lot Number: 0025169812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial