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

Model Number	1085-122-RT
Medical Device Problem Codes	Use of Device Problem (1670); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is currently in progress.The investigation results will be submitted in a supplemental mdr.H3 other text: 81.
Event or Problem Description
It was reported the device was deformed, does not maneuver, and had no visualization.No information was provided regarding patient injury, medical intervention, or extended procedure time.These are commonly used devices that are readily available.
Event or Problem Description
It was reported the device was deformed, does not maneuver, and had no visualization.No information was provided regarding patient injury, medical intervention, or extended procedure time.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
Updates to: g3, g6, h2, h3, h6, & h11.Investigation findings confirm this incident no longer falls within mdr reportability requirements as the complaint device formed a curve consistent with the reference material.The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, a kink was identified on the catheter shaft, located at approximately 58.1 cm, measured from the catheter distal tip.No further relevant visible damage was detected.The device was evaluated for curve shape and the device formed a curve consistent with the reference material.The results of the investigation determined that the reported event of, "deformed, does not maneuver" was partially confirmed, as a kink in the device shaft may have affected the catheter structural integrity, thus affecting it's maneuverability.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the most likely root cause is; the inability to maneuver the catheter/curve as a result of mishandling subsequent to distribution, including shipping/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.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.Inspect the catheter for overall condition and physical integrity.Do not use the catheter if electrodes appear loose or if any damage is noted.If such problems exist, return the catheter and packaging to stryker sustainability solutions.Advance the catheter to the region of the endocardium under investigation.Use both fluoroscopy and electrograms to assist in proper positioning.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: 17920842
• Report Number: 0002090040-2023-00015
• Device Sequence Number: 2971673
• Product Code: NLH
• UDI-Device Identifier: 00885825000172
• UDI-Public: 00885825000172
• Combination Product (Y/N): N
• Initial Reporter State: PR
• PMA/510(K) Number: K030109
• 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,Followup
• Report Date (Section B): 11/22/2023

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: 05/08/2025
• Device Model Number: 1085-122-RT
• Device Catalogue Number: 1085-122-RTRR
• Device Lot Number: 5072980SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2023
• 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