11.5FX20CM TPL LMN CATH

Additional Manufacturer Narrative

THE DEVICE INVOLVED IN THE INCIDENT WAS NOT RETURNED FOR EVALUATION AND NO PHOTOGRAPHS WERE PROVIDED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE CONTRACT MANUFACTURER CONDUCTED A REVIEW OF THE MANUFACTURING RECORDS FOR THE LOT NUMBER PROVIDED. THEIR INVESTIGATION REVEALED THE DEVICE WAS MANUFACTURED, ASSEMBLED, AND INSPECTED ACCORDING TO SPECIFICATION WITH NO NON-CONFORMANCES OR ABNORMALITIES. THE PROCEDURE FOR ATTACHING THE SUTURE WING CLEARLY IDENTIFIES THE PROCESS. THE OPERATOR ATTACHES THE SUTURE WING BY PUSHING THE WING UP ONTO THE HUB UNTIL IT IS PROPERLY SEATED IN THE CORRECT POSITION ON THE HUB AND ROTATES THE WING A FEW TIMES WHICH WOULD INDICATE CORRECT ASSEMBLY. WITHOUT AN EVALUATION OF THE DEVICE THE COMPLAINT CANNOT BE CONFIRMED, AND A ROOT CAUSE CANNOT BE DETERMINED. IT IS POSSIBLE THE DEVICE WAS SUBJECTED TO FORCES GREATER THAN THAT WHICH IT IS DESIGNED TO WITHSTAND.DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

THE DEVICE WAS FOUND NEXT TO THE PATIENT WITH THE SECURING PART STILL ATTACHED TO THE PATIENT.