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

Catalog Number	F6QF005CT
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Use of Device Problem (1670); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was a defective catheter in a case.It lost its ability to keep the curve.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 returned to stryker sustainability solutions for evaluation.The complaint device was noted to be returned in a thin envelope package.Upon visual inspection of the received complaint device, damage to the catheter's distal tip was observed.Inspection of the catheter tip revealed a bend, located 7.5 cm from the distal tip.Calibrated steel ruler sr-032 was used to identify the location of the shaft deformation.As the complaint device returned to stryker via improper shipping methods, it cannot be confirmed whether or not the damage identified during visual inspection is due to the customer's reported experience or a result of shipping and handling damage.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the likely root cause is 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 use the reprocessed ep catheter prior to completely reading and understanding the directions for use.¿ do not alter this device.¿ inspect the packaging and catheter for damage or defects prior to use.¿ avoid excessive torque, stretching, kinking and/or bending of catheter, as this may interfere with distal tip shaping or cause damage to internal electrode wires.¿ avoid manual pre-bending of distal curve, as this may damage steering mechanism of steerable catheters.Handle catheter with care to avoid improper electrical functioning.¿ avoid excessive contact of handpiece with fluids, as this could adversely affect the electrical performance of the catheter.¿ diagnostic ep catheters are not recommended for long-term pacing.¿ do not insert or withdraw the catheter without straightening the catheter tip.¿ this device should not be used with magnetic resonance imaging (mri) systems.¿ use fluoroscopic guidance during catheter 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: 20195962
• Report Number: 0002090040-2024-00013
• Device Sequence Number: 6880148
• Product Code: NLH
• UDI-Device Identifier: 00885825002183
• UDI-Public: 00885825002183
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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
• Report Date (Section B): 09/11/2024

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: 02/26/2026
• Device Catalogue Number: F6QF005CT
• Device Lot Number: 5307309SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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