DIAGNOSTIC EP CATH

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN STENOSIS PROCEDURE WITH A REPROCESSED DIAGNOSTIC EP CATHETER AND UPON OPENING THE DEVICE, SOME OF THE INTERNAL PARTS OF THE DISTAL ELECTRODES AT THE TIP OF THE CATHETER WERE EXPOSED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GET CLARIFICATION ON THIS EVENT, HOWEVER NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

Additional Manufacturer Narrative

THE PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. (B)(4).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS RECEIVED ON 16-NOV-2021. THE PRIMARY PACKAGING BOX WAS NOT OPENED BEFORE THE PROCEDURE. A NEW CATHETER WAS USED. THERE WAS NO OTHER DAMAGE NOTICED BESIDES THE DAMAGE TO THE CATHETER. IN ADDITION, MANUFACTURE DATE (10-AUG-2021) AND EXPIRATION DATE (10-AUG-2022) WERE OBTAINED, THEREFORE SECTIONS D4 AND H4 WERE UPDATED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN STENOSIS PROCEDURE WITH A REPROCESSED DIAGNOSTIC EP CATHETER AND UPON OPENING THE DEVICE, SOME OF THE INTERNAL PARTS OF THE DISTAL ELECTRODES AT THE TIP OF THE CATHETER WERE EXPOSED. THE PRODUCT WAS RETURNED TO STERILMED FOR EVALUATION. STERILMED PERFORMED VISUAL INSPECTION AND FUNCTIONAL TEST ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THE IMAGING CATHETER WAS RETURNED WITH NO APPARENT DAMAGE. MICROSCOPE ANALYSIS WAS PERFORMED IN THE TIP AREA AND THE CATHETER FAILED THE TEST. A HOLE WAS FOUND AT THE TIP WITHOUT EXPOSED WIRES. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AS PART OF STERILMED¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. ADDITIONAL INFORMATION WAS OBTAINED ON 20-DEC-2021, THAT THE DAMAGE SEEN DURING ANALYSIS IS WHAT WAS ORIGINALLY OBSERVED UPON OPENING OF THE DEVICE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).