MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION DESTINATION PERIPHERAL 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	05/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was not returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, investigation conclusions code (b)(4) has been referenced.
Event or Problem Description
The user facility reported that the destination device tip was deformed.After the right femoral artery was punctured, the guiding sheath was inserted from the puncture site, although the tip of the sheath was deformed and was difficult to be inserted in the artery.The guiding sheath was not used and replaced with another guiding sheath, which was inserted in the artery without problem.The procedure was successfully completed by contralateral approach.There was no health damage to the patient.There was no patient injury, medical/surgical intervention required.The estimated blood loss was less than 250cc.There were no other devices or equipment used with the reported product.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record of the product code/lot# combination was conducted with no findings.Ifu states: "advance or withdraw the sheath slowly.If resistance is met, do not advance or withdraw the sheath until the cause of resistance has been determined." the complaint cannot be confirmed for sheath catheter tip mechanical damage since the sample was not available for evaluation.Based on the information given, the exact root cause of the event cannot be determined.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.

• Brand Name: DESTINATION PERIPHERAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 11999675
• Report Number: 1118880-2021-00144
• Device Sequence Number: 3559775
• Product Code: DYB
• UDI-Device Identifier: 00389701008851
• UDI-Public: 00389701008851
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2021

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: 03/01/2023
• Device Model Number: N/A
• Device Catalogue Number: 54-74501
• Device Lot Number: 0000014199
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1