DISPOSABLE PRESSURE TRANSDUCER
Received Mar 18, 2025
Report 2015691-2025-02012 · MDR key 21633131
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS DISCARDED, THEREFORE, A PRODUCT EVALUATION COULD NOT BE COMPLETED. WITHOUT THE RETURN OF THE DEVICE, IT IS NOT POSSIBLE TO DETERMINE IF THERE WAS DAMAGE OR A DEFECT THAT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF ANY PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. AS THE COMPLAINT COULD NOT BE CONFIRMED, THERE IS NOT SUFFICIENT EVIDENCE TO DETERMINE A ROOT CAUSE. 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 PART OF THIS MONTHLY REVIEW.
Additional Manufacturer Narrative
THE DEVICE HAS BEEN DISCARDED AND NOT AVAILABLE FOR RETURN AND PRODUCT EVALUATION. THE MODEL AND LOT NUMBER OF THE DEVICE ARE UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. ADDITIONAL PRODUCT CODES, DQE AND DQK. THE INSTRUCTIONS FOR USE IFU PROVIDES A STATEMENT REGARDING ABNORMAL PRESSURE READINGS, PRESSURE READINGS CAN CHANGE QUICKLY AND DRAMATICALLY BECAUSE OF LOSS OF PROPER CALIBRATION, LOOSE CONNECTION, OR AIR IN THE SYSTEM. AN ENGINEERING EVALUATION HAS BEEN INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT.
Description of Event or Problem
IT WAS REPORTED DURING USE OF EDWARDS DISPOSABLE PRESSURE TRANSDUCER DPT AND INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE ICF100 THE BALLOON PRESSURE WAS MEASURED INACCURATELY BY THE DPT IN 7 CASES. EVENT SPECIFICS ARE NOT AVAILABLE FOR THE PREVIOUS 7 CASES. DURING THE CASE ASSOCIATED WITH MEDWATCH 2015691-2025-01990 THE FIELD REPRESENTATIVE PERFORMED TROUBLESHOOTING WITH THE CLINICAL TEAM TO DETERMINE IF ANY USE ISSUES WERE AFFECTING THE DPTS BALLOON PRESSURE VALUES. IT WAS FOUND THAT THE PERFUSIONIST WAS NOT DE AIRING THE PRESSURE SYSTEM CORRECTLY AND AIR WAS AT THE SENSOR. THE FIELD REPRESENTATIVE TRAINED THE PERFUSIONIST AND TEAM ON THE CORRECT PROCESS FOR PRIMING THE DPT TO REMOVE ALL AIR.