HOFF PASS-LONG

Additional Manufacturer Narrative

WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. PLEASE REFER TO COMPLAINT (B)(4). AN INITIAL IS BEING GENERATED RECLASSIFYING THE EVENT TO A SERIOUS INJURY. UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE EVALUATION OF THE INSTRUMENT REVEALED EXCESSIVE WEAR THROUGHOUT. THE PASSER WAS VERY TIGHT WITHIN THE SHEATH AND WAS DIFFICULT TO REMOVE. EXCESSIVE FRICTION WAS FELT WHEN REMOVING THE PASSER AND CAUSED THE METAL TO SCRAPE. THE SHEATH IS BENT NOT ALLOWING FOR PROPER FIT OF THE PASSER. IT IS LIKELY THAT MANIPULATION OF THE SHEATH OVER TIME RESULTED IN BENDING/POOR FIT. THE DATE OF MANUFACTURE (OR ANOTHER MARKING) IS NOT VISIBLE, HOWEVER; INSTRUMENT APPEARS TO BE OLD. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

Description of Event or Problem

CUSTOMER REPORTED THAT SHUNT PASSER SHEATH IS DEFECTIVE AND METAL ON METAL FRICTION HAS RESULTING IN METAL SHAVINGS. NO PATIENT INJURY AS RESULT OF DEFECT. WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. PLEASE REFER TO COMPLAINT (B)(4). AN INITIAL IS BEING GENERATED RECLASSIFYING THE EVENT TO A SERIOUS INJURY.