MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. STEERABLE DIAGNOSTIC EP CATHETER SUPER LARGE CURL, 7F; CATHETER, RECORDING, ELECTRODE, REPROCESSED

Model Number	N/A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During atrial flutter ablation procedure, it was reported that livewire could not easily be placed in desired location.At one point, different sheaths were used as dilators, eventually it was determined that the catheter placement was not adequate, had to be removed, and dr [redacted] asked for another livewire.Livewire in report was removed and another placed without issue.

• Brand Name: STEERABLE DIAGNOSTIC EP CATHETER SUPER LARGE CURL, 7F
• Common Device Name: CATHETER, RECORDING, ELECTRODE, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 w. drake dr; tempe AZ 85283
• MDR Report Key: 21873148
• Report Number: 21873148
• Device Sequence Number: 8742308
• Product Code: NLH
• UDI-Device Identifier: 00885825007263
• UDI-Public: (01)00885825007263
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/15/2025
• Report Date (Section F): 04/15/2025

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 Model Number: N/A
• Device Catalogue Number: 401904
• Device Lot Number: 5456689
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Unknown
• Patient Weight: 100 KG
• Date Report Sent to FDA: 04/15/2025