MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. VIEWFLEX ICE CATHETER; REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reprocessed ice (intracardiac echocardiography) catheter inserted into the patient via 10 french sheath in the left femoral vein.Device had imagery on the monitor, and proceduralist noted that the image was poor.Proceduralist did fluoro of the device and noted that the tip of the ice catheter was at an acute non-normal angle and was moving under fluoro.Device was retrieved with no patient harm and procedure continued with a new device.Manufacturer response for reprocessed intravascular ultrasound catheter (per site reporter).Vendor rep would like to pick item up for evaluation.

• Brand Name: VIEWFLEX ICE CATHETER
• Common Device Name: REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 5900 optical ct.; san jose CA 95138
• MDR Report Key: 19219978
• Report Number: 19219978
• Device Sequence Number: 8241643
• Product Code: OWQ
• UDI-Device Identifier: 07613327376067
• UDI-Public: (01)07613327376067
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 04/12/2024
• Report Date (Section F): 04/12/2024

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 Model Number: N/A
• Device Catalogue Number: D087031
• Device Lot Number: 5308575
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Male
• Patient Weight: 122 KG
• Date Report Sent to FDA: 04/12/2024