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

Model Number	N/A
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the wire seemed to have a prominent weld that prevented the wire from passing through the needle.There was no patient injury, or blood loss.The procedure was successful, and the patient was in stable condition.
Additional Manufacturer Narrative
Patient identifier: requested, not provided.Age & date of birth: requested, not provided.Patient sex: requested, not provided.Weight: requested, not provided.Ethnicity: requested, not provided.Race: requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: cardio lab manager.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.A review of the device history record of the product code/lot# combination was conducted with no findings.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 to update section h3 and to provide the completed investigation results.One gss needle and guidewire were returned for product evaluation.The guidewire was bent at two places measured to be 15.5cm and 29cm from the stiff end.The guidewire was not able to be passed through the needle.The guidewire od was measured to be 0.0200", and the specification is <= 0.021in.The needle id was measured to be 0.021", and the specification is >=0.55mm [0.0216"].All measurements were within the manufacturer's specifications.A loose coil was discovered at the point where the guidewire could not pass through the needle.This was measured to be 5.7cm from the floppy end.The compliant can be confirmed for guidewire mobility issues because the guidewire was unable to pass through the needle.This was caused by the loose coil region on the guidewire which caused it to catch on the hub of the needle.The exact root cause of this uncoiling could not be determined.Review of device history record (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 design failure mode & effects analysis (dfmea).

• Brand Name: GLIDESHEATH SLENDER
• Common Device Name: 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: gina digioia ; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15446374
• Report Number: 1118880-2022-00072
• Device Sequence Number: 4679759
• Product Code: DYB
• UDI-Device Identifier: 00389701012049
• UDI-Public: 00389701012049
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2024
• Device Model Number: N/A
• Device Catalogue Number: 80-1050
• Device Lot Number: 0000182925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown