COUPLER
Received Sep 26, 2025
Report 1416980-2025-04855 · MDR key 23160345
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
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 ¿6-10%¿ MEAN/AVERAGE THROMBOSIS RATE OBSERVED IN THE PAST 12 MONTHS WHEREIN A COUPLER WAS UTILIZED FOR AN UNSPECIFIED REASON DURING AN UNSPECIFIED PROCEDURE. THE RESPONDENT ADDITIONALLY STATED, ¿THIS IS ABOUT THE NORMAL EXPECTED RATE FOR MY CASES.¿ THESE EVENTS LIKELY REQUIRED MEDICAL INTERVENTION IN ORDER TO PRECLUDE PERMANENT IMPAIRMENT. THE RESPONDENT ANSWERED ANONYMOUSLY; THEREFORE, FOLLOW UP INFORMATION WAS NOT ABLE TO BE OBTAINED. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.