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

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that they were unable to mount the destination introducer in the artery, the dilator comes out less than usual from the introducer.There was no harm to the patient.Additional information was received on 24may2023: the procedure was a right iliac angioplasty and right femoral tripod by crossover.The device did not appear to be damaged.There was no stenosis, plaque, calcium present around the insertion site.The patient condition was stable.Another introducer of the same reference was used to complete the procedure and was compliant.The procedure outcome was successful.The estimated blood loss was less than 250cc.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.A review of the device history record of the product code and lot number combination was conducted with no findings.The actual device has not been received yet for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.
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 6fr destination dilator and sheath were returned for product assessment.No visual abnormalities were seen on the length nor tips of the dilator nor sheath.The sheath was measured to be 46.5cm from the hub to the tip, and the specification was 43-47 cm.The dilator extension from the tip of the sheath was measured to be 3cm, and the specification is 1.5-3.0 cm.The sheath outer diameter (od) was measured to be 0.112" and the specification is= 0.114".All measurements were within specifications.The complaint cannot be confirmed for insertion difficulties as no deformation of the sheath tip nor dilator was present, and the sheath outer diameter (od) and dilator extension measurements were within specifications.The exact root cause of the insertion difficulty could not be determined.Review of 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 failure mode and effects analysis (fmea).

• 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 ; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 17056677
• Report Number: 1118880-2023-00132
• Device Sequence Number: 8536644
• Product Code: DYB
• UDI-Device Identifier: 00389701006161
• UDI-Public: 00389701006161
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2023

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: 06/01/2025
• Device Model Number: N/A
• Device Catalogue Number: RSR01
• Device Lot Number: 0000295924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 07/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2022
• 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: TERUMO GUIDE 0.35 180CM
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White