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

Model Number	M00568201
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Impact code: code f19 captures the reportable event of surgical intervention.Code f23 captures the reportable event of unexpected medical intervention.
Event or Problem Description
It was reported to boston scientific corporation that an endovive safety peg kit pull method was used during an esophagogastroduodenoscopy with percutaneous endoscopic gastrostomy placement procedure on (b)(6) 2023.During procedure, the angiocath needle was inserted, upon pulling out, part of the sheath detached and dislodged inside the patient.A surgery was performed to retrieve the detached portions.There were reported patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an endovive safety peg kit pull method was used during an esophagogastroduodenoscopy with percutaneous endoscopic gastrostomy placement procedure on (b)(6) 2023.During procedure, the angiocath needle was inserted, upon pulling out, part of the sheath detached and dislodged inside the patient.A surgery was performed to retrieve the detached portions.There were reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block e4: this event was reported to the fda via a voluntary medwatch report.The report number is 0501500000-2023-8003.Block h6 (impact code): code f19 captures the reportable event of surgical intervention.Code f23 captures the reportable event of unexpected medical intervention.Block h10: the returned trocar was analyzed.The feeding tube was not returned.Visual analysis of the device revealed that the trocar needle had punctured the sheath and was torn.Therefore, the reported complaint is confirmed.Based on the condition of the returned device, engineers determined that the problem observed could be caused by handling of the device during use; perhaps the technique used, or patient's anatomical conditions could have contributed to this event.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.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Block e4 (initial reporter also sent rep to fda) has been corrected.

• Brand Name: ENDOVIVE STANDARD 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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16452088
• Report Number: 3005099803-2023-00976
• Device Sequence Number: 5835397
• Product Code: KNT
• UDI-Device Identifier: 08714729285199
• UDI-Public: 08714729285199
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: M00568201
• Device Catalogue Number: 6820
• Device Lot Number: 0030405131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown