NA
Received Sep 8, 2022 · Event occurred Aug 30, 2022
Report 0002090040-2022-00001 · MDR key 15387155
Device
Generic name
Catheter, Recording, Electrode, Reprocessed
Manufacturer
Stryker Sustainability Solutions PhoenixModel number
81104Catalog number
81104RR
Lot number
4785608SH
Product problems
- Use of Device Problem
- Use of Device Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. UPON INSPECTION OF THE RECEIVED COMPLAINT DEVICE, THE DEVICE DID NOT MEET THE CURVE SPECIFICATION BUT DID 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 MOST LIKELY ROOT CAUSE IS 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 CATHETER THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST MARKET SURVEILLANCE.
Description of Event or Problem
IT WAS REPORTED THE COMPLAINT DEVICE HAD AN 'S' SHAPE THAT WOULD CORRECT OUT OF THE BODY WHEN STRAIGHTENED, BUT THEN WOULD GO BACK TO THE 'S' SHAPE WHEN IN THE BODY. THE PHYSICIAN USED X-RAY TO POSITION AND REPOSITION THE DEVICE DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THE COMPLAINANT IS NOT AWARE OF ANY OTHER MEDICAL INTERVENTION OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Additional Manufacturer Narrative
THE DEVICE INVESTIGATION IS CURRENTLY IN PROGRESS. INVESTIGATION RESULTS WILL BE INCLUDED IN A SUBSEQUENT SUPPLEMENTAL MDR.
Description of Event or Problem
IT WAS REPORTED THE COMPLAINT DEVICE HAD AN 'S' SHAPE THAT WOULD CORRECT OUT OF THE BODY WHEN STRAIGHTENED, BUT THEN WOULD GO BACK TO THE 'S' SHAPE WHEN IN THE BODY. THE PHYSICIAN USED X-RAY TO POSITION AND REPOSITION THE DEVICE DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THE COMPLAINANT IS NOT AWARE OF ANY OTHER MEDICAL INTERVENTION OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.