COUPLER
Received Nov 7, 2025
Report 1416980-2025-05539 · MDR key 23495798
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 WAS ASKED ¿DID THE FLAP CREATED USING THE FLOW COUPLER SURVIVE? THE CLINICIAN RESPONDED: ¿NO." ADDITIONALLY, WHEN ASKED ¿DID YOU ACHIEVE PATENCY USING THE FLOW COUPLER?¿ THE CLINICIAN RESPONDED: ¿NO." THESE EVENTS LIKELY REQUIRED SURGICAL INTERVENTION IN ORDER TO PRECLUDE PERMANENT IMPAIRMENT. THE RESPONDENT ANSWERED ANONYMOUSLY; THEREFORE, FOLLOW UP INFORMATION COULD NOT BE OBTAINED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.