MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION GLIDESHEATH; INTRODUCER, CATHETER

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

The actual device is not available, however an unused sample is available and has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, investigation conclusions code 11 has been referenced in section h6.A review of the device history record of the product code/lot# combination was conducted with no findings.

Event Description

The user facility reported that the glildesheath had a leaky valve.There was not patient injury/medical or surgical intervention required.The patient was in stable condition.The procedure outcome was successful.There were no other devices or equipment used with the reported product.Additional information was received on (b)(6).2020.The estimated blood loss was less than 250cc.The procedure was completed using the device.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the completed investigation results.H6: investigation findings - 114 is based upon the evaluation of user facility information and the investigation of the photograph provided by the user facility; 3221 is based upon the actual device not being returned.H6 - investigation conclusion - 4310 is based upon evaluation of the user facility information and the investigation of the photograph provided by the user facility; 4315 is based the actual device not being returned.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted, however the investigation of the photographs provided by the user facility was conducted.The complaint can be confirmed for fluid issues.Based on the information given, the exact root cause of the event cannot be determined.There is no indication that any manufacturing, design or quality system issues may have led to this event.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the fmea.

• Brand Name: GLIDESHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 11078327
• MDR Text Key: 223826168
• Report Number: 1118880-2020-00341
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00389701011264
• UDI-Public: 00389701011264
• Combination Product (y/n): N
• PMA/PMN Number: K152173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 30-2560
• Device Lot Number: YF13
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1