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

Model Number	RSR01
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that normal access was obtained in the left common femoral artery, and the entry sheath was exchanged for the destination sheath.An angiogram of the right leg was performed.Upon completion, the destination sheath was attempted to be removed via the normal procedure.However, the sheath became "stuck," and additional force was applied to remove it.The sheath eventually pulled free, but it was determined that it had separated in situ, with the distal portion remaining inside the body.A cut down was performed, and the distal portion of the sheath was successfully retrieved.However, a subsequent angiogram revealed a portion of "metallic coiling" remaining in situ.An attempt to remove it with a snare was unsuccessful, and the "metallic coiling" was left behind.The procedure performed was a right leg peripheral angiogram, and there was no blood loss.
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.E3: occupation: vascular surgeon.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.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section d9, section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.One destination kit was returned for product evaluation.The returned sample included the sheath and dilator.The returned sample was subjected to visual analysis.The dilator was not inserted into the sheath.There were multiple breakage points on the sheath.All pieces were held together by the coiling and the tip and hub ends were present.There was no damage found on the dilator.The complaint can be confirmed for sheath separation.The exact root cause cannot be determined.The likely root cause is the sheath became stuck because of some 'unknown' resistance.The device history record (dhr) review determined that the device was in a conforming state when released from terumo control.There is no indication that any manufacturing issues may have led to this event.Action item was initiated to address the occurrence breach.
Event or Problem Description
Additional information was received on 15 jan 2025: no other device was used with metallic coiling was used during the procedure.

• Brand Name: DESTINATION
• 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: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 20808615
• Report Number: 1118880-2024-00179
• Device Sequence Number: 9940943
• Product Code: DYB
• UDI-Device Identifier: 00389701006161
• UDI-Public: (01)00389701006161(17)261201(10)0000621400
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2024

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 Model Number: RSR01
• Device Catalogue Number: RSR01
• Device Lot Number: 0000621400
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 11/29/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• 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: Other; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Race: White