COUPLER
Received Sep 17, 2025
Report 1416980-2025-04658 · MDR key 23077882
Device
Generic name
Device, Anastomotic, Microvascular
Manufacturer
Baxter Healthcare CorporationModel number
NICatalog number
NI
Lot number
NI
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Thrombosis/Thrombus
- Thrombosis/Thrombus
Narrative
Description of Event or Problem
DURING A SURVEY, AN UNSPECIFIED HEALTHCARE WORKER RESPONDED ¿90-94% FLAP SURVIVAL RATE¿ WHEREIN A COUPLER WAS UTILIZED FOR AN UNSPECIFIED REASON DURING AN UNSPECIFIED PROCEDURE. ADDITIONALLY, THE RESPONDENT STATED, ¿IN CASES OF SIZE MISMATCH, THROMBOSIS SEEMS TO OCCUR MORE FREQUENTLY, EVEN IN IRRADIATED PATIENTS.¿ PER THE INSTRUCTIONS FOR USE (IFU) ¿USING A RING TOO LARGE FOR THE VESSEL MAY RESULT IN STRESSING OR TEARING THE VESSEL WALL AND A COMPROMISED ANASTOMOSIS. USING A RING TOO SMALL FOR THE VESSEL MAY UNDULY CONSTRICT THE VESSEL AND LEAD TO THROMBOSIS OR RING SEPARATION¿. THE VESSEL MEASURING GAUGE IS TO BE USED TO APPROXIMATE THE SIZE. THIS EVENT LIKELY REQUIRED MEDICAL INTERVENTION IN ORDER TO PRECLUDE PERMANENT IMPAIRMENT. THE RESPONDENT ANSWERED ANONYMOUSLY; THEREFORE, FOLLOW UP INFORMATION WAS NOT ABLE TO BE OBTAINED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.