TRUWAVE, VAMP PLUS
Received Oct 2, 2025
Report 2015691-2025-08047 · MDR key 23199225
Device
Generic name
Transducer, Pressure, Catheter Tip
Manufacturer
Edwards Lifesciences DrModel number
PXVP23X3Lot number
66526323
Product problems
- Contamination
- Contamination
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT RETURN OF THE UNIT, IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND NO RELATED NON-CONFORMANCES WERE FOUND. AS PART OF THE MANUFACTURING PROCESS 100% OF THE UNITS UNDERGO A VISUAL INSPECTION, CONTINUOUS MONITORING SAMPLING, AND A QA SAMPLING INSPECTION.
Description of Event or Problem
IT WAS REPORTED THAT BEFORE USE OF THE PRESSURE MONITORING SET, A BUG WAS FOUND INSIDE THE TUBING. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Additional Manufacturer Narrative
ADDITIONAL FDA PRODUCT CODE INCLUDES: KRA- CATHETER, CONTINUOUS FLUSH. THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.