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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.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.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 glidesheath slender was used during the procedure.A fisulagram was performed by the doctor, routine procedure using a 5/4 glidesheath slender via radial access.Bard 035 ultaverse 6x60 used during procedure and inflated three times.The balloon was being removed and was stuck inside access sheath.The md removed the balloon and the balloon was stuck in sheath, causing a separation of sheath from hub.The patient's condition was stable.The procedure outcome was successful.There was no patient injury, medical/surgical intervention required.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information in section b5, to update section h3, and to provide the completed investigation results.One 5fr 10cm glidesheath slender with a 6x60, 5fr lutonix balloon was received for product evaluation.No other components were received for product evaluation.Visual inspection of the sheath and balloon revealed that the sheath was folded in reverse and exited through the valve in the opposite direction with the balloon stuck within it.The inner diameter of the tip of the sheath was measured to be 1.80 mm which is within manufacturer specifications.The balloon was attempted to be removed from the sheath, although high resistance was observed.Ifu states: " do not manipulate intraluminal devices if any resistance is met.Failure to exercise proper caution may lead to deformation of the sheath tube due to its thin wall, resulting in damage to the vessel." based on the returned device, the complaint can be confirmed for the sheath/catheter mechanical separation.The device was in a conforming state when released from terumo control.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.
Event or Problem Description
Additional information was received on april 12, 2021.The french size of the balloon was a 6f.

• Brand Name: GLIDESHEATH SLENDER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 11445146
• Report Number: 1118880-2021-00037
• Device Sequence Number: 19843784
• Product Code: DYB
• UDI-Device Identifier: 00389701012049
• UDI-Public: 00389701012049
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2021

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: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 80-1050
• Device Lot Number: XH31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 04/27/2021
• 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: BD ULTRAVERSE.; BD ULTRAVERSE.
• Patient Age: 73 YR
• Patient Weight: 103