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 Codes	Foreign Body In Patient (2687); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D6a: implanted date: the device was not implanted.D6b: explanted date: the device was not explanted.E3: occupation: department supervisor.The actual device was not 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 r2p device became stuck when the radial artery seemed to spasm down on the sheath during removal.The physician seemed to have also have difficulty inserting the sheath.Ultrasound was not used to measure the artery ahead of time, but several vasodilators were injected before the short sheath was exchanged for the 119cm as well as during the removal process.The inner dilator was also inserted for the removal however the dilator came halfway back in the sheath, leaving the sheath without it as the radial artery clamped down with spasm.The sheath then started to unravel as the physician proceeded to pull in out of the radial artery.We tried several different methods to help assist withe removal including sedation medication, nitro pastes to the arm, nitro sublingual, hot compression, manual bp cuff inflated and released, and multiple vasodilators through given through the sheath.A vascular surgeon was notified and took the patient to surgery for a brachial cutdown and removal of the foreign body.The patient did well during the surgical procedure, but a portion of the radial artery had to be removed.The estimated blood loss was greater than 250cc's.Additional information was received on 08nov2023: the separated r2p sheath was never returned due to the radial artery being partially attached to the device after removal.
Event or Problem Description
Additional information was received on 17nov2023: the interventional cardiologist stated that the cut down and partial removal of the radial artery was successful.The patient did not have any additional complications during or after the surgery.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide the additional information in section b5 and 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 cannot be confirmed for sheath separation because a sample was not returned for assessment.Without a sample, the exact root cause cannot be determined.The likely root cause is the sheath was withdrawn during a patient spasm and due to the increased resistance, the sheath separated.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: 18117248
• Report Number: 1118880-2023-00429
• Device Sequence Number: 7707536
• 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): 11/11/2023

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: 11/01/2025
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C12W
• Device Lot Number: 0000352451
• 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: 10/12/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 11/11/2023
• Supplement Report FDA Received Date: 12/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HOT COMPRESSION; MANUAL BP CUFF INFLATED AND RELEASED; MULTIPLE VASODILATORS; NITRO PASTE TO THE ARM; NITRO SUBLINGUAL; SEDATION MEDICATION
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female