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

Catalog Number	D087031
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was torturous, so cath team upsized to 12fr x 30cm from 10fr x 23cm.Proceduralist put the catheter up the ivc (inferior vena cava), remarked on the image, and then when he torqued the catheter to enter the right atrium, ultrasound image was lost.Cath team pulled the catheter out and upon inspection the tip was broken at a 45-degree angle to the catheter shaft with a visible split.Manufacturer response for reprocessed intravascular ultrasound catheter, n/a (per site reporter).Stryker did phone conference with hospital to advise of steps they are taking to investigate concern.

• Brand Name: VIEWFLEX ICE
• Common Device Name: REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; 1810 w. drake dr.; tempe AZ 85283
• MDR Report Key: 19369665
• Report Number: 19369665
• Device Sequence Number: 18020004
• 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): 05/01/2024
• Report Date (Section F): 05/01/2024

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 Catalogue Number: D087031
• 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: 05/22/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2024
• 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: 82 YR
• Patient Sex: Unknown
• Patient Weight: 68 KG
• Date Report Sent to FDA: 05/01/2024