COUPLER
Received Nov 6, 2025
Report 1416980-2025-05528 · MDR key 23490603
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
- Stenosis
- Stenosis
Narrative
Description of Event or Problem
DURING A SURVEY, AN UNSPECIFIED HEALTHCARE WORKER WAS ASKED ¿DID YOU OBSERVE ANY ADVERSE EVENTS DURING OR UP TO TWELVE WEEKS POSTOPERATIVELY WITH A FLOW COUPLER?¿ THE CLINICIAN RESPONDED: ¿STENOSIS, SITUATION DETAILS: FINE." THE EVENT LIKELY REQUIRED SURGICAL REVISION 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.
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.