MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION PINNACLE INTRODUCER, CATHETER

Model Number RSS501

Device Problems Defective Device (2588); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 08/13/2021

Event Type  malfunction  

Event Description

5fr terumo pinnacle sheath (ref# rss501, lot# 000003555): used for a mesenteric angio for y90 (yttrium-90) planning, the stopcock holes on the sheath are not in the correct spots, allowed air into sheath. Manufacturer error. Sheath was inserted into patient, defect was identified upon flushing, sheath had to be removed from patient and a new sheath opened.

• Brand Name: PINNACLE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 12391404
• Report Number: 12391404
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: RSS501
• Device Catalogue Number: RSS501
• Device Lot Number: 000003555
• 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: 08/23/2021
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown
• Patient Age: 27010 DA