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

Model Number	M00568201
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	05/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report source: medwatch number is (b)(4).(b)(4).
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 placement procedure on (b)(6) 2022.During the procedure, when the dilator was gently pulled through the skin, it detached leaving the peg tube in the stomach.It was able to be retrieved and the procedure was repeated.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 placement procedure on may 7, 2022.During the procedure, when the dilator was gently pulled through the skin, it detached leaving the peg tube in the stomach.It was able to be retrieved and the procedure was repeated.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block g3: medwatch number is (b)(4).Block h6 (device codes): device code a0501 captures the reportable event of peg tube detached.Block h10: the returned endovive standard peg tube and rigid tubing were analyzed.The rigid tube was found cut proximal to the joint.In addition, the retrieval loop portion of the device was also returned and was noted the loop shaft had been cut proximal to the loop.The peg tube is cut to size after placement, and this cut occurs on the peg portion of the device and not the rigid tubing or loop end.The reported event was confirmed.Based on the condition of the returned device, engineers determined that the problem observed is possibly due to some cutting force.Based on a review of all available information, the cause of the reported event could not be determined.The correct device was returned.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A product labeling review identified that the device was used per the directions for use (dfu) / 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: 14645471
• Report Number: 3005099803-2022-03151
• Device Sequence Number: 20257273
• Product Code: KNT
• UDI-Device Identifier: 08714729285199
• UDI-Public: 08714729285199
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2022

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: 10/17/2022
• Device Model Number: M00568201
• Device Catalogue Number: 6820
• Device Lot Number: 0029040770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 43 KG
• Patient Race: White