MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION R2P¿ DESTINATION SLENDER¿ GUIDING SHEATH

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: the device was not implanted.D6b: explanted date: the device was not explanted.E3: occupation: cardiologist.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.
Event or Problem Description
The user facility reported that they were pulling the r2p sheath out of the patient after the procedure, and it came apart.There was no patient injury and/medical or surgical intervention required.Additional information as received on 10nov2023: the case was an r2p case.The patient did not experience a spasm when the device removal was taking place.No injury or medical intervention took place due to the device coming apart.The estimated blood loss was less than 250cc.The patient was stable.
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; therefore, an evaluation of the actual device was unable to be conducted.The complaint can be confirmed for sheath separation based on the photos provided by the account.Without a sample, the exact root cause cannot be determined.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: R2P¿ DESTINATION SLENDER¿ GUIDING SHEATH
• Common Device Name: GUIDING SHEATH
• 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 ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 18167397
• Report Number: 1118880-2023-00422
• Device Sequence Number: 6622142
• Product Code: DYB
• UDI-Device Identifier: 00389701011547
• UDI-Public: 00389701011547
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2023

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: 04/01/2025
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C12W
• Device Lot Number: 0000246879
• 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: 10/20/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2023
• Supplement Report FDA Received Date: 12/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2023
• 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 Age: 50 YR
• Patient Sex: Female