MAUDE Adverse Event Report: GIVEN IMAGING VIETNAM CO LTD VERSAFLEX; ELECTRODE, PH, STOMACH

Model Number	957970
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Discomfort (2330)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, the calibration and other pre-sequence operations of the catheter were normal.After the catheter was placed, the patient was uncomfortable.The patient did not bite the catheter.The operator was careful during the operation and did not see the catheter enter the oral cavity.The electrode was removed and the tip of the electrode was found to be broken.The broken tip of the electrode was inside the patient's body.The break was sharp.At the same time, blood was found on the surface of the electrode.It passed through the nasal cavity to the stomach and the bleeding was within this range.No gastroscopy was done, and there was no specific bleeding site.The event lead to or extend patient hospitalization.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Additional information: d4 (udi), d9, g3, h3, h6.H3.Evaluation summary: medtronic conducted an investigation based upon all information received.The device and photos were available for evaluation.Visual inspection noted that the end of the catheter was broken and was completely separated from the remainder of the catheter.It was reported that the versaflex catheter tip broke and there was unintentional disengagement of device/component into the patient and was not retrieved.The reported issues were confirmed.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: VERSAFLEX
• Common Device Name: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING VIETNAM CO LTD; suite 6a, 6th floor; ho chi minh city ; VM
• Manufacturer (Section G): GIVEN IMAGING VIETNAM CO LTD; suite 6a, 6th floor; ho chi minh city ; VM
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20683768
• Report Number: 3007662958-2024-00011
• Device Sequence Number: 15592697
• Product Code: FFT
• UDI-Device Identifier: 04260167483931
• UDI-Public: (01)04260167483931(17)250311(10)F2337203UA
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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: 03/11/2025
• Device Model Number: 957970
• Device Catalogue Number: 957970
• Device Lot Number: F2337203UA
• 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: 10/29/2024
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 24 MO
• Patient Sex: Male
• Patient Weight: 15 KG