NA
Received Dec 30, 2021 · Event occurred Nov 17, 2021
Report 0002090040-2021-00048 · MDR key 13122005
Device
Generic name
Catheter, Recording, Electrode, Reprocessed
Manufacturer
Stryker Sustainability Solutions PhoenixModel number
81945Catalog number
81945RR
Lot number
4517815
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED CATHETER WAS NOT HOLDING SHAPE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 20 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Additional Manufacturer Narrative
A REVIEW OF MDRS FILED FROM AUGUST 24, 2017, TO JULY 19TH, 2022, WAS CONDUCTED. SINCE AUGUST 24TH, 2017, THERE HAS BEEN ONE ADDITIONAL REPORT (RESTARTING THE TWO-YEAR REPORTING CYCLE ON 01/15/2020) OF SERIOUS INJURY OR SURGICAL INTERVENTION TO PRECLUDE SERIOUS INJURY OR PERMANENT IMPAIRMENT RELATED TO THIS SPECIFIC FAILURE MODE. BASED ON THE ANALYSIS OF MDR DATA COMPARED TO THE FIRM¿S SALES FIGURES, THE LIKELIHOOD OF THIS SPECIFIC FAILURE MODE CAUSING OR CONTRIBUTING TO ANOTHER SERIOUS INJURY SHOULD THE MALFUNCTION OCCUR IS CONSIDERED NEGLIGIBLE. AS SUCH, WE WILL NO LONGER BE REPORTING FOR THE FAILURE MODE OF A DEFLECTABLE EP CATHETER DEVICE HAVING A BEND ALONG WITH CURVE SHAPE AND PLANARITY THAT DO NOT MEET SPECIFICATION.
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. UPON INSPECTION OF THE RECEIVED COMPLAINT DEVICE, A BEND WAS IDENTIFIED 10 CM FROM THE DISTAL TIP, WHICH IS DISTAL TO THE TRANSITION POINT. THE HANDLE, STEERING KNOB, CONNECTOR, AND ELECTRODES APPEARED TO BE INTACT. THE DEVICE WAS EVALUATED FOR DEFLECTION. THE DEVICE DID NOT MEET CURVE SPECIFICATIONS. THE DEVICE DID NOT MEET THE PLANARITY SPECIFICATION. A REVIEW OF THE DHR SUPPORTS THAT THE DEVICE MET ALL INSPECTION AND TEST CRITERIA PRIOR TO RELEASE FROM STRYKER. THE REPORTED EVENT COULD BE ATTRIBUTED TO MISHANDLING SUBSEQUENT TO DISTRIBUTION, INCLUDING SHIPPING/STORAGE CONDITIONS OR IMPROPER MANIPULATION OF THE CATHETER. THE INSTRUCTIONS FOR USE (IFU) STATE: DO NOT EXERT EXCESSIVE PRESSURE DURING PLACEMENT OF CATHETER IF UNKNOWN RESISTANCE IS ENCOUNTERED. DO NOT ATTEMPT TO USE THE REPROCESSED EP CATHETER PRIOR TO COMPLETELY READING AND UNDERSTANDING THE DIRECTIONS FOR USE. AVOID MANUAL PRE-BENDING OF DISTAL CURVE, AS THIS MAY DAMAGE STEERING MECHANISM OF STEERABLE CATHETERS. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST-MARKET SURVEILLANCE.
Description of Event or Problem
IT WAS REPORTED CATHETER WAS NOT HOLDING SHAPE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 20 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.