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

Model Number	RSR04
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that a registered nurse (rn) and an interventional cardiologist were performing a heart catheterization on a patient.Due to the patient's tortuous iliac anatomy, a 7fr x 45cm destination guiding sheath (rsr04) was utilized to provide additional support during the procedure.At the conclusion, the destination sheath was withdrawn, and it began to unravel near the tip.A portion of the sheath broke off and remained in the patient, necessitating surgical intervention for removal.The surgical intervention was successful, and the patient is now stable.The event occurred intra-operatively.Estimated blood loss was less than 250cc.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: age & date of birth: requested, not provided.A3a: sex: requested, not provided.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D4: lot #: requested, not provided.D4: expiration date: unknown, as the involved lot # was not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.H4: device manufacture date: unknown, as the involved lot # was not provided.The actual device is not available for return.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.The production lot # was not provided by the user facility, which prevented a meaningful review of the device history record.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide the completed investigation results.The actual device was not returned, so an evaluation could not be conducted.Since the sample was not available for evaluation, the complaint cannot be confirmed for sheath separation.The exact root cause cannot be determined.Device history record (dhr) review cannot be performed due to the lot number being unknown.Currently, no action is recommended since the risk evaluation is within the predetermined limits in hazard based risk table (hbrt).

• 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: 22391515
• Report Number: 1118880-2025-00091
• Device Sequence Number: 8930635
• Product Code: DYB
• UDI-Device Identifier: 00389701006192
• UDI-Public: 00389701006192
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

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: RSR04
• Device Catalogue Number: RSR04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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