COUPLER
Received Oct 21, 2025
Report 1416980-2025-05193 · MDR key 23347517
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 THAT AN UNSPECIFIED NUMBER OF PATIENTS UNDERWENT AN ANASTOMOSIS OF VEINS AND ARTERIES IN MICRO-SURGICAL AND/OR VASCULAR RECONSTRUCTIVE PROCEDURE. DURING AND/OR UP TO TWELVE WEEKS POST OPERATIVE ANASTOMOTIC PATENCY WAS COMPROMISED, AND THE FREE FLAP WAS NOT SALVAGED WITH A COUPLER. ADDITIONALLY, THE RESPONDENT STATED, ¿THE DEVICE FAILED TO PROVIDE ACCURATE READINGS THAT ALIGNED WITH THE CLINICAL OBSERVATIONS MADE BY THE SURGICAL TEAM.¿ THESE EVENTS LIKELY REQUIRED MEDICAL/SURGICAL 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.