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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Telephone number: (b)(6).The actual device has not been 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.
Event or Problem Description
The user facility reported that the wire included with the glidesheath slender sheath unraveled.Additional information was received on 09jul2021.The user facility stated that the wire looked fine going into the needle while sitting in the radial artery, however the doctor could not insert it, so they repositioned the needle.As the doctor came out with the wire to reinsert, he noticed that it had unraveled.A new wire was used for the same sheath as the problem was with the wire.There was no impact on the patient.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to update section h3, and to provide the completed investigation results.One 7 fr glidesheath guidewire was returned for product evaluation and no other components were returned for evaluation.The guidewire was subjected to visual analysis and was observed to be unraveling.The full length of the wire segment measured at 42 cm and the unraveling of the wire starts at 35 cm from the floppy end.The outer coiling of the tip portion of the breakage was completely uncoiled and stretched.The complaint can be confirmed for guidewire mechanical separation/break due to the damage noted on the sample and the breakage.Based on the available information, the exact root cause of the event cannot be determined however it is possible that maneuvering the guide wire inside the needle likely contributed to the failure.The device was in a conforming state when released from terumo control.There is no indication that any manufacturing issues may have led to this event.Currently no action is recommended since this risk evaluation is within the predetermined limits in the fmea.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.

• Brand Name: GLIDESHEATH SLENDER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 12199322
• Report Number: 1118880-2021-00168
• Device Sequence Number: 14468716
• Product Code: DYB
• UDI-Device Identifier: 00389701011370
• UDI-Public: 00389701011370
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2021

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: 06/01/2023
• Device Model Number: N/A
• Device Catalogue Number: 50-1070
• Device Lot Number: 0000027978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 07/23/2021; 08/25/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 08/16/2021; 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NEEDLE