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

Model Number N/A

Device Problems Off-Label Use (1494); Use of Device Problem (1670)

Patient Problems Pain (1994); Pallor (2468)

Event Date 12/07/2021

Event Type  Injury  

Manufacturer Narrative

The actual device was not returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.The product code/lot # combination was not provided by the user facility, which prevented a meaningful review of the device history record.This report is for the second device reported, for the first device (tr band) reported that was used on the same patient see mdr 1118880-2021-00220.

Event Description

The user facility reported that the treating physician injected air from the tr band inflator into the sheath hub of the glide sheath slender device involved, instead of the tr band inflation balloon.When air was injected into the sheath hub the patient became transiently ill, then made a full recovery.The procedure outcome was successful.The patient was in stable condition.The estimated blood loss was less than 250cc's.The procedure performed was a neurovascular embolization.The amount of air injected into the sheath hub was 18 milliliters.The sheath was immediately aspirated with removal of a small amount of air.The patient soon became pale with diminished responsiveness that lasted for approximately two minutes.There was no change in blood pressure or oxygen saturation, although a small increase in end tidal carbon dioxide was noted.The patient gradually became more responsive without focal deficit and within a relatively short time had returned to baseline neurologic function.The arterial sheath was removed.The patient noted mild pain in the right hand that was soon resolved.Hemostasis was successfully achieved.There was no direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint cannot be confirmed because the sample was not returned for assessment.The cause of the patient becoming ill was that air was pumped into sheath in the patient instead of the tr band.Review of dhr showed there were no issues noted during manufacture of the product that could have contributed to this complaint condition.Currently no action is recommended since this risk evaluation is within the predetermined limits in the failure mode and effects analysis (fmea).

• Brand Name: GLIDESHEATH SLENDER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 13598929
• MDR Text Key: 290552035
• Report Number: 1118880-2022-00010
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 02/25/2022
• Supplement Dates Manufacturer Received: 03/16/2022
• Supplement Dates FDA Received: 03/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TR BAND
• Patient Outcome(s): Other; Required Intervention