COUPLER
Received Sep 30, 2025
Report 1416980-2025-04884 · MDR key 23183199
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
H11: 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 THE COUPLER WHEN USED FOR ANASTOMOSIS OF VEINS AND ARTERIES IN MICRO-SURGICAL AND/OR VASCULAR RECONSTRUCTIVE PROCEDURES ¿SOMETIMES DON¿T CLOSE FULLY AND NEED TO REVISE THE WHOLE ANASTOMOSIS.¿ SURGICAL REVISION OF THE ANASTOMOSIS DURING SURGERY IS CONSIDERED AS PART OF THE SURGICAL PROCEDURE. A RING NOT CLOSING FULLY WOULD BE DETECTED AND CAN RESULT IN THE NEED TO REVISE THE ANASTOMOSIS. 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.