MAUDE Adverse Event Report: SYNOVIS LIFE TECHNOLOGIES, INC. FLO-THRU INTRALUMINAL SHUNT; CLAMP, VASCULAR

Model Number	FT12125
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the white thread (tether) of a flo-thru intraluminal was not centered on the blue tube.The surgeon discovered this problem when they were about to place it inside the patient during operation; however, it was not used on the patient.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H11: the device was received for evaluation.A visual inspection was performed, and the suture knot on the middle shaft being uncentered was observed.While the knot and suture of the flo-thru device was confirmed to be off center, the functionality of the device was not impacted.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: FLO-THRU INTRALUMINAL SHUNT
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): SYNOVIS LIFE TECHNOLOGIES, INC.; deerfield IL
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20321849
• Report Number: 1416980-2024-05311
• Device Sequence Number: 20809128
• Product Code: DXC
• UDI-Device Identifier: 00085412532448
• UDI-Public: (01)00085412532448(10)SP23F081886563(17)280329
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K981624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2024

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: Other
• Device Model Number: FT12125
• Device Catalogue Number: FT12125
• Device Lot Number: SP23F081886563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2023
• 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: Unknown