TRUWAVE
Received Jun 30, 2026
Report 2015691-2026-16481 · MDR key 25670743
Device
Generic name
Transducer, Pressure, Catheter Tip
Manufacturer
Edwards Lifesciences DrModel number
PX600ILot number
66782059
Product problems
- Loose or Intermittent Connection
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT, DURING USE, MULTIPLE TRUWAVE TRANSDUCERS HAD LOOSE CONNECTIONS AND REQUIRED RETIGHTENING. THE TRANSDUCERS WERE ATTACHED TO AN EVD ATTACHMENT. THERE WAS NO LEAKAGE AND NO ALLEGATIONS OF PATIENT HARM. QUANTITY IS UNKNOWN.
Additional Manufacturer Narrative
ADDITIONAL PREMARKET SUBMISSION: K171996. ISSUE OCCURRED WITH 2 OTHER LOT NUMBERS. ADDITIONAL MDRS WERE SUBMITTED AGAINST THE OTHER LOT NUMBERS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE REPORT IDS ARE AVAILABLE. DEVICES WILL NOT BE RETURNED. WITHOUT THE 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. WITH THE PROVIDED LOT NUMBER, A DEVICE HISTORY RECORD WAS COMPLETED AND THE PRODUCT PASSED WITHOUT NONCONFORMANCES. 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.