MAUDE Adverse Event Report: CORDIS CORPORATION TEMP5 SIM2 ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 451-531H2

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/27/2021

Event Type  malfunction  

Event Description

Dr.(b)(6) began with left femoral access with a 5f 23cm brite tip sheath for diagnostic cerebral angiography.Glidewire passed through sheath with a 5f cordis tempo simmons 2100 cm diagnostic catheter, and catheter advanced through previously placed aaa endograft up to arch for diagnostic cerebral imaging.Upon torquing the catheter to position in the aortic arch, the body of the catheter sheared, appearing to have caught on the edge of the left iliac portion of the endograft stent and separating into 2 halves.The proximal portion of the catheter was removed through the sheath, with guidewire access maintained through the distal portion of the catheter.Right femoral artery access was achieved with an 8f 45cm sheath, and proceeding through the aaa endograft into the thoracic aorta.A loop snare was passed through this sheath up to the aortic arch, and the snare was manipulated around the distal tip of the simmons catheter.Once snared, the simmons catheter was removed through the 8f sheath, and the remainder of the diagnostic procedure was able to be completed without additional adverse event.The sheared catheter has been retained in the angiography department.

• Brand Name: TEMP5 SIM2 ANGIOGRAPHIC CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION
• MDR Report Key: 11260714
• MDR Text Key: 230126173
• Report Number: MW5099111
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 451-531H2
• Device Catalogue Number: 451-531H2
• Device Lot Number: 17934440
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 75