MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE SAFETY PEG KIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	M00509030
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an endovive safety peg kit push method was attempted to be used in the gastric during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2024.During the procedure, the peg tube broke upon pulling.The procedure was completed with another endovive safety peg kit push method.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (device codes): imdrf device code a0501 captures the reportable event of peg tube detached.
Event or Problem Description
It was reported to boston scientific corporation that an endovive safety peg kit push method was attempted to be used in the gastric during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2024.During the procedure, the peg tube broke upon pulling.The procedure was completed with another endovive safety peg kit push method.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (device codes): imdrf device code a0501 captures the reportable event of peg tube detached.Block h11: one initial g-tube separated at the barb connector was received for analysis.Visual inspection did not note any exterior kinks or damage on the thermoformed tubing or the feeding tube.Visual inspection of the barb connector showed damage to both the body of the barb connector that is usually connected to the thermoformed tubing along with the crimp ring.No other problems with the device were noted.With all the available information, boston scientific concludes that the reported event of peg tube detached was confirmed.Upon analysis, damage was noted to the barb connector, specifically to the crimp ring and to the barb connector body underneath in the form of a fold/bend/crimp.As the barb connector is positioned in between the feeding tube and the thermoformed tubing, damage to the barb connector is likely to affect the connection between the barb connector and the tubing.As such, it is possible that damage to the crimp ring, likely caused by excessive force or rough handling during procedure, caused the barb connector to separate from the thermoformed tubing when the device was pulled.Based on all gathered information, the most probable cause for the reported allegation is unintended user error, which indicates that interaction between the device and the user caused or contributed to the error.

• Brand Name: ENDOVIVE SAFETY PEG KIT
• Common Device Name: 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; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19940775
• Report Number: 3005099803-2024-03726
• Device Sequence Number: 11981136
• Product Code: PIF
• UDI-Device Identifier: 08714729880448
• UDI-Public: 08714729880448
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K150679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: M00509030
• Device Catalogue Number: 57707
• Device Lot Number: 0033797601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown