COUPLER
Received Sep 22, 2025
Report 1416980-2025-04715 · MDR key 23116420
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
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
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.
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. THE RESPONDENT STATED, ¿THAT IS OVERALL FLAP SURVIVAL RATE. IT IS NOT ALWAYS RELATED TO THE VENOUS ANASTOMOSES OR CANNOT BE ATTRIBUTED TO THE DEVICE SPECIFICALLY. OTHER COMPLICATING FACTORS INHERENT IN THE FLAP ARE SOMETIMES THE ISSUE.¿ ADDITIONALLY, ¿I USUALLY ONLY USE FOR THE VENOUS ANASTOMOSES. AT TIMES THE DEVICE BECOMES ¿STICKY¿ TO DEPLOY THE COUPLER, WHICH CAN CAUSE ADDITIONAL TRAUMA TO THE VESSEL. THERE HAVE BEEN THE RARE OCCASION WHERE THE TWO ENDS DO NOT SEAL WELL AND A SECOND COUPLER IS NEEDED.¿ 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.