COUPLER
Received Oct 17, 2025
Report 1416980-2025-05163 · MDR key 23328855
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
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Thrombosis/Thrombus
- 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 DURING THE ANASTOMOSIS OF VEINS AND ARTERIES IN MICRO-SURGICAL AND/OR VASCULAR RECONSTRUCTIVE PROCEDURE WITH A COUPLER OR UP TO 12 WEEKS POST-SURGICAL THAT AN UNKNOWN QUANTITY OF PATIENTS HAD COMPROMISED ANASTOMOTIC PATENCY. ADDITIONALLY, THE RESPONDENT STATED, ¿NO¿ FOR THE QUESTION DID THE DEVICE ALLOW FOR SALVAGE OF A COMPROMISED FREE FLAP. THE RESPONDENT ADDITIONALLY STATED ¿INTRISIC ISSUE. CLOTTED. PATIENT WITH ISSUE.¿ FURTHERMORE, THE RESPONDENT ANSWERED NO TO QUESTION REGARDING FLAP SURVIVAL. 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.