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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: requested, not provided.Weight: (b)(6).Ethnicity: requested, not provided.Race: requested, not provided.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.(b)(4).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.They had radial access in left radial artery.At the end of procedure, the catheter and wire were removed.The valve broke and blood was pouring out of the end of the sheath.The estimated blood loss was less than 250cc.The patient's condition was fine, no injuries.There was no negative outcome of the procedure.There was no patient injury, medical/surgical intervention required.Additional information was received on 30nov2020.The procedure being performed was a diagnostic cardiac catheterization.The wire and catheter were being removed from the sheath when the valve broke.The patient's condition was stable.
Additional Manufacturer Narrative
One 6fr glidesheath sheath was received for product evaluation.Visual inspection revealed no damage on the device.A blood like substance was noted throughout the side tube and the sheath shaft.The sheath was then subjected to leak testing.The distal end of the sheath was inserted into a 12 fr balloon.The distal end of the balloon was connected to a controlled air supply system.The 3-way stopcock (3wsc) was closed, and the air pressure was increased to 4.3 psi (equivalent to 222 mmhg).The setup was submerged underwater for approximately 30 seconds.Air bubbles were observed.A dilator for investigational purposes was then inserted into the sheath.This assembly was submerged in water, and air bubbles were detected for 30 seconds.To check for damage at the crosscut valve, the valve was dissected and observed under microscope.Damage was observed at the center of the crosscut valve.The complaint can be confirmed for crosscut valve mechanical damage due to the damage noted on the valve.Based on the investigation, the likely cause of the event is off-center insertion of the dilator and significant off axis maneuvering resulting in damage of the crosscut valve.The damage noted at the crosscut valve likely caused the leakage.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.

• Brand Name: GLIDESHEATH SLENDER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 11018549
• Report Number: 1118880-2020-00328
• Device Sequence Number: 4396532
• Product Code: DYB
• UDI-Device Identifier: 00389701011233
• UDI-Public: 00389701011233
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K152173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 30-1060
• Device Lot Number: YF20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 68