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

Model Number	M00568201
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact age of the patient is unknown.However, it was reported the patient was over 18 years old.Device code a0414 captures the reportable event of peg tube torn inside patient.
Event or Problem Description
It was reported to boston scientific corporation that an endovive standard peg kit pull method was used during a percutaneous endoscopic gastrostomy tube placement procedure on (b)(6) 2023.During the procedure, while the peg tube was being pulled, the tube became torn.The procedure was completed with a new endovive standard peg kit pull method.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an endovive standard peg kit pull method was used during a percutaneous endoscopic gastrostomy tube placement procedure on (b)(6) 2023.During the procedure, while the peg tube was being pulled, the tube became torn.The procedure was completed with a new endovive standard peg kit pull method.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block a2: the exact age of the patient is unknown.However, it was reported the patient was over 18 years old.Block h6 (device codes): device code a0414 captures the reportable event of peg tube torn inside patient.Block h10: one endovive safety peg tube was returned for analysis.Visual assessment was performed.It was noted that bolster end of the tube had detached from the shaft, the detached portion appeared to have a cut mark and a tear adjacent to the cut.The shaft side was inspected and found a matching cut or tear that lined up with portion of the bolster side, indicating it was unlikely any material detached.In addition, the pull wires had detached.The reported complaint was confirmed.Based on the condition of the returned device, engineers determined that the problem observed is likely that the tubing was first cut by some interaction with another device during use, such as the scissors or hemostats that may have been used in the case.One cut was placed on the tubing and subsequent pulling during placement of the tube caused the tube to tear at the location of the cut.A strong pulling force was found on the device in the form of torn pull wires at the opposite end of the device.In addition, an operational factor, such as user technique/handling could have contributed to the reported complaint.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.

• 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: 16490823
• Report Number: 3005099803-2023-01118
• Device Sequence Number: 6994260
• Product Code: KNT
• UDI-Device Identifier: 08714729285199
• UDI-Public: 08714729285199
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K031538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 03/31/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: M00568201
• Device Catalogue Number: 6820
• Device Lot Number: 0030812244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2023
• 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: Female