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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device has not 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.
Event or Problem Description
The user facility reported that the involved destination device introducer was withdrew when the operator had major difficulties despite the implementation a rigid guide to facilitate the removal.A significant elongation was noted on the device which frayed at the level of the skeleton metal, and which ended up breaking in the patient's artery.Clinical consequences and status of the patient involved was need for a conversion to have open surgery by approaching the scarpa on the right.Simple follow-up actions taken for the patient in relation to the dm.The tip of the introducer with the entire metal skeleton was removed without difficulty with forceps.The patient condition was not harmed.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.2 to provide the device return date in section d9, to update section h3 and to provide the completed investigation results.One 6fr destination sheath was returned for assessment.The sheath was separated 23.3cm from the sheath tip, with the inner coil unraveled and exposed.The sheath was kinked 4cm from the sheath tip.Mechanical deformation was present throughout the entire proximal half of the sheath.The complaint can be confirmed for sheath separation based on the state of the sheath.The exact root cause of the sheath separation could not be determined.According to the complaint description, the likely root cause of the sheath separation was that it became stuck in the patient's artery and the user continued to forcible remove the sheath despite resistance.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 design failure mode and effects analysis (dfmea).
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 to provide the completed investigation results.The actual device has not been returned; therefore, an evaluation of the actual device was unable to be conducted.When the device is returned the complaint will be reopened.H6: investigation findings: code 3211 is based upon the complaint description and investigation of the image provide; code 3221 is based upon no device return.H6: investigation conclusions: code 44 is based upon the complaint description and investigation of the image provide; code 4315 is based upon no device return.The complaint can be confirmed for sheath separation based on the state of the sheath in the image provided.The exact root cause of the sheath separation could not be determined.According to the complaint description, the likely root cause of the sheath separation was that it became stuck in the patient's artery and the user continued to forcible remove the sheath despite resistance.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 design failure mode and effects analysis (dfmea).

• Brand Name: DESTINATION PERIPHERAL 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: 15971696
• Report Number: 1118880-2022-00091
• Device Sequence Number: 6059660
• Product Code: DYB
• UDI-Device Identifier: 50389701007781
• UDI-Public: 00389701007786
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2022

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: 06/01/2024
• Device Model Number: N/A
• Device Catalogue Number: RSP01
• Device Lot Number: 0000136308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Supplement Date Received by Manufacturer: 01/06/2023; 02/24/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/10/2023; 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown