MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION DESTINATION RENAL GUIDING SHEATH; 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	06/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a peripheral arterial disease (pad) procedure via right leg access from the left common femoral artery (cfa), the destination device involved was advanced up and over a very calcified and steep bifurcation.The procedure was completed but upon removal of the device, the sheath skin tore exposing the coil inside.Hemostasis was achieved with an 8fr angio-seal.The procedure was completed.The event occurred intra-operative.The estimated blood loss was less than 250cc.The patient was in stable condition.The procedure outcome was completed.
Additional Manufacturer Narrative
Date of birth: requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: registered technician (rt).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 number 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 7fr destination sheath was returned for evaluation.The sheath was separated with the coil holding the two separated pieces together.The separation was measured to occur 30.5cm from the hub.The sheath had two pinch points, one measured to be 2.6cm from the tip, and the other 9.5 cm from the tip.The complaint can be confirmed for sheath separation based on the condition of the returned device.The exact root cause could not be determined.The likely root cause is that withdrawing the sheath over the very calcified and steep bifurcation caused the sheath to separate.Review of the 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 and effects analysis (dfmea).

• Brand Name: DESTINATION RENAL GUIDING SHEATH
• 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: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 14770828
• Report Number: 1118880-2022-00034
• Device Sequence Number: 1334833
• Product Code: DYB
• UDI-Device Identifier: 00389701006192
• UDI-Public: 00389701006192
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K172995
• 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): 06/22/2022

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: 08/01/2024
• Device Model Number: N/A
• Device Catalogue Number: RSR04
• Device Lot Number: 0000157837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 8FR ANGIO-SEAL
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White