MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION DESTINATION RENAL GUIDING SHEATH; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A4: weight: requested, not provided.A6: race: requested, not provided.D6a: implanted date: device was not implanted.D6b: 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 involved r2p device was used during a left brachial access approach for treating a right ostial sfa.The balloon was not able to be advanced because the sheath had kink.The procedure could not be completed.Estimated blood loss was less 250 ccs.The patient was not injured, medical or surgical intervention was not required.Patient condition was stable.Procedure had to be stopped.The event occurred intra-operative.
Event or Problem Description
Additional information was received on 25 jul 2023: the procedure was completed on another day.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide additional information in section b5, to update section h3 and to provide the completed investigation results.One r2p sheath and dilator assembly was returned to for assessment.The sample was subject to visual analysis.The dilator is inserted and locked into the sheath.There is a kink on the sheath 0.7-1.0 cm from the sheath hub.The hub is screwed in tight to the sheath.No other damage is noted on the sheath.The complaint can be confirmed for sheath damage because the returned sample is kinked near the hub.The exact root cause cannot be determined.The likely root cause is the sheath kinked during the procedure and prevented the balloon from advancing.The sheath used during the procedure was expired and terumo does not validate the use of devices after expiration.Review of device history record (dhr) showed there were no issues noted during the 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: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 17421592
• Report Number: 1118880-2023-00382
• Device Sequence Number: 13018118
• Product Code: DYB
• UDI-Device Identifier: 00389701011547
• UDI-Public: 00389701011547
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2023

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: 04/30/2022
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C12W
• Device Lot Number: XN06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 07/29/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2019
• 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: METACROSS BALLOOON
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic