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

Model Number M00568251

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/10/2023

Event Type  malfunction  

Manufacturer Narrative

E4: this event was reported to the fda via a voluntary medwatch report.The report number is 4500440000-2023-8044.H6 (device codes): imdrf device code a0501captures the reportable event of peg tube detached.

Event Description

It was reported to boston scientific corporation that an endovive standard peg kit push was used during a percutaneous endoscopic gastrostomy tube placement on (b)(6) 2023.During the procedure, the peg tube came apart, causing it to be separated inside and outside the patient's body.The physician still had the device in hand and was able to put it back together without changing the device.The procedure was completed with the same original endive standard peg kit push.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: 17170961
• MDR Text Key: 317553933
• Report Number: 3005099803-2023-03239
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 08714729296805
• UDI-Public: 08714729296805
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K031538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/21/2023

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 Model Number: M00568251
• Device Catalogue Number: 6825
• Device Lot Number: 0030178572
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: White