MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION R2P DESTINATION SLENDER; INTRODUCER, CATHETER

Model Number	GS-R6ST1C75W
Medical Device Problem Codes	Material Separation (1562); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided due to hospital policy.A2: age & date of birth: requested, not provided due to hospital policy.A3a: sex: requested, not provided due to hospital policy.A3b: gender: requested, not provided due to hospital policy.A4: weight: requested, not provided due to hospital policy.A5: ethnicity: not provided for animal use.A6: race: not provided for animal use.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: buyer.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.
Event or Problem Description
The user facility reported that the sheath broke into two pieces near the hub.The procedure performed was a cardiac angioplasty.There was no injury or blood loss reported.Additional information was received on 29nov2024: the device was not being used on the patient at the time the breakage occurred.There were no particles of the sheath inside the patient.There was no plaque or stenosis present at the insertion site.The patient was stable.The procedure was completed using a second destination slender.The procedure was successful.The customer added the following comments: when removing the introducer from its hoop-sheath, the metal of the introducer was loose and deformed.We used another one afterward, and everything was properly in place.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.One r2p sheath was returned for assessment.The sample was subject to visual analysis.The sheath hub is separated and uncoiling.The sheath is kinked 2.3-3.7cm from the sheath tip.The sheath hub was placed under x-ray to check for the swage band.The swage band was identified under x-ray imaging.The band is shifted from its normal position in the sheath hub.The sheath hub was cut open to identify the layers of the r2p sheath.Upon opening the sheath hub, the inner layer, outer layer, strain relief and metal coil were identified.The complaint can be confirmed for sheath hub separation.The exact root cause cannot be determined.The likely root cause is the user pulled on the hub, leading to the separation.The operations quality engineer was notified about this issue and determined it is likely not a manufacturing issue as all layers of the sheath were identified and the swage band is present in the sheath hub.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with terumo medical corporation specifications and procedures and the device was released in a conforming state.Currently, no action is recommended since the risk evaluation is within the predetermined limits in the hazard based risk table (hbrt).

• Brand Name: R2P DESTINATION SLENDER
• 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 ; 4103927218
• MDR Report Key: 20878029
• Report Number: 1118880-2024-00195
• Device Sequence Number: 18353669
• Product Code: DYB
• UDI-Device Identifier: 00389701012360
• UDI-Public: (01)00389701012360(17)250501(10)0000286263
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K193125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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: 05/01/2025
• Device Model Number: GS-R6ST1C75W
• Device Catalogue Number: GS-R6ST1C75W
• Device Lot Number: 0000286263
• 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: 11/18/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2022
• 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
• Patient Sex: Unknown