COUPLER
Received Sep 17, 2025
Report 1416980-2025-04656 · MDR key 23078202
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
- Thrombosis/Thrombus
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 ¿6-10% FOR THE ATTRIBUTE MEAN AVERAGE THROMBOSIS¿ WHEREIN A COUPLER WAS UTILIZED FOR AN UNSPECIFIED REASON DURING AN UNSPECIFIED PROCEDURE. ADDITIONALLY, THE RESPONDENT STATED, ¿I HAVE HAD A FEW EARLY THROMBOSIS NEAR THE ANASTOMOSIS SITE.¿ 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.