MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE OSB KIT PULL W/ENFIT 24F 3.4CM; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number M00509670

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

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

Event Date 09/21/2021

Event Type  Injury  

Manufacturer Narrative

This event was reported by the distributor.The physician is: (b)(6).(b)(4).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 procedure, when the catheter was being pulled through the abdominal wall out of the body, the folded encased wings of the one step button device exited the abdominal wall.The bolster then detached and stayed between the stomach wall and the abdominal wall.The physician retrieved the bolster.The 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 OSB KIT PULL W/ENFIT 24F 3.4CM
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 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: 12636172
• MDR Text Key: 276593450
• Report Number: 3005099803-2021-05229
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K161003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2024
• Device Model Number: M00509670
• Device Catalogue Number: 57741
• Device Lot Number: 0027305810
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other