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

Model Number	N/A
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted; explanted date: device was not explanted.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.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 physician attempted to insert the destination guiding sheath to the artery after the dilator was set to the guiding sheath, however, it was difficult to insert the guiding sheath due to high resistance.The physician, therefore, withdrew the guiding sheath.The tip of the guiding sheath was found to be deformed, and this made the guiding sheath difficult to be inserted.The guiding sheath was not used, and replaced with a competitor's guiding sheath to continue the procedure.The procedure was successfully completed.The blood loss was less than 250cc's.There was no health damage to the patient.There was no patient injury, medical/surgical intervention required.There were no other devices, or equipment used with the reported product.
Additional Manufacturer Narrative
The actual device was not returned to the manufacturing facility for evaluation.However, two unused samples were returned for evaluation.The involved device was not returned for evaluation.Therefore, the investigation was based on user facility information and evaluation of the unused samples.The complaint cannot be confirmed for sheath catheter tip mechanical damage per the information received.Based on the information given, the exact root cause of the event cannot be determined, although it is likely that the sheath tip was damaged due to high resistance.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 failure mode and effects analysis (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: 10905717
• Report Number: 1118880-2020-00300
• Device Sequence Number: 2881850
• 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): 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 54-74501
• Device Lot Number: YF13
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention