MAUDE Adverse Event Report: STRYKER-ENDOSCOPY PHOENIX USA; CATHETER, RECORDING, ELECTRODE, REPROCESSED

Model Number	BD710FJ282RTS
Medical Device Problem Codes	Mechanical Problem (1384); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter would not steer when they went to use it.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The device was retuned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, little to no tactile feedback was experienced when deflecting the catheter in the j-curve direction.The inability to fully deflect the device's j-curve indicates damage to the internal steering wire.No further relevant visible damage was observed.The catheter handle, deflection/ locking mechanism in the f direction, and distal tip appeared to be intact.The device met the curve and planarity specification in the f direction, however, the catheter failed curve and planarity specifications in the j direction.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: curve failure as a result of mishandling subsequent to distribution, including shipping and storage conditions or improper manipulation of the device.The instructions for use (ifu) state: do not attempt to operate the catheter prior to completely reading and understanding the applicable instructions for use.Always place the rocker lever in the neutral position to straighten the catheter tip before insertion or withdrawal of the device.Do not use excessive force to advance or withdraw the catheter.Careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.Use both fluoroscopy and electrograms to monitor the advancement of the device to the area of the endocardium under investigation to avoid vascular or cardiac damage.Tactile feedback of reprocessed devices may vary during use.Inspect the catheter and package before opening.The contents of the package are sterile unless the package is opened or damaged.If the package is damaged or if it was opened and the catheter not used, do not use the catheter.Return the catheter and packaging to stryker sustainability solutions.Storage and handling: prior to use, store reprocessed ep catheters in a cool, dry, dark place.The reported event will continue to be monitored through post-market surveillance.

• Brand Name: NA
• Common Device Name: CATHETER, RECORDING, ELECTRODE, REPROCESSED
• Manufacturer (Section D): STRYKER-ENDOSCOPY PHOENIX USA; 10232 s. 51st st.; phoenix AZ 85044
• Manufacturer (Section G): STRYKER-ENDOSCOPY PHOENIX USA; 10232 s. 51st st.; phoenix AZ 85044
• Manufacturer Contact: andy dobos ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 20207229
• Report Number: 0002090040-2024-00014
• Device Sequence Number: 7676405
• Product Code: NLH
• UDI-Device Identifier: 00885825000288
• UDI-Public: 00885825000288
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K100254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/08/2026
• Device Model Number: BD710FJ282RTS
• Device Catalogue Number: BD710FJ282RTS
• Device Lot Number: 5317749SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown