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

Model Number	M00566460
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an endovive safety peg kit pull method was attempted to be used during an esophagogastroduodenoscopy (egd) procedure.The procedure date was unknown.During the procedure, when the user pulled the g-tube through the abdomen, the pull wire broke.The procedure was able to be completed successfully with the original peg kit pull method.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0401 captures the reportable event of pull wire broken.
Event or Problem Description
It was reported to boston scientific corporation that an endovive safety peg kit pull method was attempted to be used during an esophagogastroduodenoscopy (egd) procedure.The procedure date was unknown.During the procedure, when the user pulled the g-tube through the abdomen, the pull wire broke.The procedure was able to be completed successfully with the original peg kit pull method.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0401 captures the reportable event of pull wire broken.Block h11: the returned endovive safety peg kit pull method was analyzed.One pull method peg tube with the retrieval loop and one pull wire was returned for analysis.Visual inspection of the end of the loop confirmed the presence of damage in the form of a break.Visual inspection of the pull wire noted the presence of a tight knot/loop which was most likely the portion of the retrieval loop that broke.The pull wire was returned detached.No other problems with the device were noted.With all available information, boston scientific concludes the reported event of pull wire break was confirmed during the product investigation.Based on the condition of the returned device, it is possible that excessive force/tension applied during use caused the retrieval loop and pull wire to strain and subsequently break/detach.Therefore, the most probable root cause is adverse event related to procedure.

• Brand Name: ENDOVIVE SAFETY PEG KIT
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• 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: 19120578
• Report Number: 3005099803-2024-01757
• Device Sequence Number: 18200182
• Product Code: KNT
• UDI-Device Identifier: 08714729748380
• UDI-Public: 08714729748380
• Combination Product (Y/N): Y
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K031538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/05/2024

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: 08/31/2024
• Device Model Number: M00566460
• Device Catalogue Number: 6646
• Device Lot Number: 0031892302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2022
• 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