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

Model Number RSS602

Device Problem Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 09/09/2020

Event Type  malfunction  

Event Description

Defective connection of side port stopcock of 6 french pinnacle introducer sheath.Fda safety report id# (b)(4).

• Brand Name: INTRODUCER, CATHETER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORP. ; elkton MD 21921
• MDR Report Key: 10527905
• MDR Text Key: 206996210
• Report Number: MW5096580
• Device Sequence Number: 1
• Product Code: DYB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: RSS602
• Device Catalogue Number: RSS602
• Device Lot Number: YE15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Is the Reporter a Health Professional?: 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: 69 YR