MAUDE Adverse Event Report: COOK MEDICAL / TERUMO MEDICAL CORP. 5FR TERUMO PINNACLE SHEATH

Model Number 68097

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212); Physical Resistance (2578)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/01/2018

Event Type  Injury  

Event Description

The patient was prepped and draped for an arteriogram in an attempt at revascularization.The left common artery was accessed under ultrasound guidance.During the course of ending the procedure and pulling the sheath back there was resistance the proximal portion of the sheath separated from the distal end and patient needed to be taken to the operating room immediately to extract the remaining portion of the sheath.Product 5fr.Terumo pinnacle sheath.

• Brand Name: 5FR TERUMO PINNACLE SHEATH
• Type of Device: 5FR TERUMO PINNACLE SHEATH
• Manufacturer (Section D): COOK MEDICAL / TERUMO MEDICAL CORP.
• MDR Report Key: 7376860
• MDR Text Key: 103823297
• Report Number: MW5076183
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/26/2018

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
• Device Operator: Health Professional
• Device Model Number: 68097
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 83