MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE OSB KIT PULL W/ENFIT 24F 4.4CM; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number M00510230

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/24/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(evaluation conclusion codes): the device has not been received for analysis.Upon receipt and completion of the problem 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 procedure on (b)(6) 2021.During the procedure, the internal bolster detached.The procedure was completed with a new endovive one step button.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block h6 (device codes); device problem code a0501 captures the reportable event of internal bolster detached.Block h10: an endovive one step button was returned.Visual analysis of the one step button revealed that the bolster was present, and it was undeployed.Therefore the complaint of bolster detached was not confirmed.However, the pull wire dilating tip was detached.Based on the condition of the returned device, engineers determined that the failure mode observed may be related to user manipulation and/or some technique applied while setting up the device and submitting some tension that ended detaching the pull wire dilating tip.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.It is most likely that the adverse event occurred during the procedure and the device had no influence on event which led to the reported 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 procedure on (b)(6), 2021.During the procedure, the internal bolster detached.The procedure was completed with a new endovive one step button.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: ENDOVIVE OSB KIT PULL W/ENFIT 24F 4.4CM
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11849637
• MDR Text Key: 251461695
• Report Number: 3005099803-2021-02255
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): Y
• PMA/PMN Number: K161003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2023
• Device Model Number: M00510230
• Device Catalogue Number: 57741
• Device Lot Number: 0025507026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/19/2021
• Supplement Dates Manufacturer Received: 06/21/2021
• Supplement Dates FDA Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1