MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE STANDARD PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number M00568401

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/14/2023

Event Type  malfunction  

Manufacturer Narrative

Device code a0501 captures the reportable event of peg tube detached.

Event Description

It was reported to boston scientific corporation that an endovive standard peg kit push method was used during an endoscopic gastrostomy procedure on (b)(6), 2023.During the procedure, it was reported that when the physician exerted force while pushing the peg tube through the abdominal cavity it detached.The procedure was completed with a new endovive standard peg kit push method.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 (device codes): imdrf device code a0501 captures the reportable event of peg tube detached.Block h10: one endovive standard peg push was returned.Visual analysis of the device revealed that the thermoformed tubing was detached to the connector.Media inspection showed that the pull wire assembly connection broke and one section was lodged inside the tubing.Therefore, the reported complaint is confirmed.Based on the condition of the returned device, engineers determined that the problem observed could be related to procedural and anatomical factors encountered during the procedure; the user technique, patient anatomy or other procedural factors such the incision size and force applied during placement could have broken the pull wire assembly detaching the component from the tubing.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.

Event Description

It was reported to boston scientific corporation that an endovive standard peg kit push method was used during an endoscopic gastrostomy procedure on (b)(6) 2023.During the procedure, it was reported that when the physician exerted force while pushing the peg tube through the abdominal cavity it detached.The procedure was completed with a new endovive standard peg kit push method.There were no patient complications reported as a result of this event.

• Brand Name: ENDOVIVE STANDARD PEG KIT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• 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: 16517724
• MDR Text Key: 311163116
• Report Number: 3005099803-2023-01194
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): Y
• Reporter Country Code: CO
• PMA/PMN Number: K031538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00568401
• Device Catalogue Number: 6840
• Device Lot Number: 0027895018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2021
• 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 Age: 60 YR
• Patient Sex: Female
• Patient Weight: 60 KG