COUPLER
Received Oct 21, 2025
Report 1416980-2025-05215 · MDR key 23352120
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
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, ¿LIMITED OPTION SOMETIMES.¿ 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.
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.