MAUDE Adverse Event Report: TERUMO MEDICAL CORP. PINNACLE; INTRODUCER, CATHETER

Model Number 9F

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Thrombosis (2100)

Event Date 10/17/2016

Event Type  malfunction  

Event Description

The md was flushing/prepping the sheath and noticed the faulty valve.The sheath never went into the patient's body, there was no harm to patient.

• Brand Name: PINNACLE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORP.; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 6431651
• MDR Text Key: 70782966
• Report Number: 6431651
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: 9F
• Device Catalogue Number: RSS901
• Device Lot Number: UH27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR