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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter: occupation: materials management.The actual device was not available; therefore, the actual device will not be returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.A review of the device history record of the product code/lot number combination was conducted with no findings.
Event or Problem Description
The user facility reported that upon completing procedure, the destination slender started "threading" (unraveling).The sheath separated and a portion of the distal end remained in the artery.The doctor was able to remove the distal segment safely and applied a tr band.Per the doctor, there was no injury to the patient or artery.The patient was stable, and the procedure outcome was a success.Additional information was received on 08 dec 2022: the procedure performed for the patient, at the time was a lower extremity intervention with left radial access.There were no difficulties with arterial access, sheath, guidewire, or catheter insertion.A pre-deployment angiogram was performed.There was only difficulty during withdrawal.Difficulty removing and then the device broke in half.The dilator was in the sheath during removal.The estimated blood loss was less than 250cc.The doctor stated that it was possible patient spasm had occurred.He also mentioned that he may have underestimated the patient's artery size.If a spasm did occur there was no medical intervention necessary.
Additional Manufacturer Narrative
This report is being submitted 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 cannot be confirmed for sheath separation because the sample was not returned for assessment.The exact root cause could not be determined.The likely root cause is the sheath encountered a spasm during withdraw and forcing withdraw during a spasm may have caused the separation.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 use failure modes & effects analysis (ufmea).

• Brand Name: R2P¿ DESTINATION SLENDER¿ GUIDING SHEATH
• 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: gina digioia ; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15988147
• Report Number: 1118880-2022-00092
• Device Sequence Number: 6089540
• Product Code: DYB
• UDI-Device Identifier: 50389701012365
• UDI-Public: 00389701012360
• Combination Product (Y/N): N
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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: 05/01/2024
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C75W
• Device Lot Number: 0000104786
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• 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