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 Codes	Device Embedded In Tissue or Plaque (3165); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the involved r2p destination slender was inserted through the radial artery to perform a peripheral intervention.Once intervention was completed the r2p destination was being removed and the radial artery spasmed.As the doctor tried to remove the r2p destination slender elongated and severed and the distal part of the sheath remained in patient.Vascular surgery was called and needed to perform a cutdown surgery to remove sheath.The event occurred intra-operative.The patient was in stable condition.The procedure outcome was successful.Additional information was received on 05 jun 2023: the patient was given medication to treat the spasm when is occurred.Concomitant medical products used with the r2p was balloons.
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter occupation: cath lab manager the actual device has been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
This report is being sent as follow-up #1 to update section h3, and to provide the completed investigation results.One r2p sheath and dilator were returned for evaluation.The sample was subject to visual analysis.The dilator is partially inserted into the sheath.The sheath is separated at 119.2 cm from the sheath hub.The sheath coil is unraveling at the tip of the dilator.The outer layer of the sheath is separated from the coil and stretched at the tip of the dilator.The sheath hub is not damaged.The broken piece of sheath without the dilator is 47.5 cm in length.The broken piece has kinks along the sheath.The breakage point is torn.The sheath tip is not damaged or deformed.The complaint can be confirmed for sheath separation.The exact root cause could not be determined.The likely root cause is the sheath was attempted to be removed during increased resistance from a patient spasm.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: 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 ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 17149609
• Report Number: 1118880-2023-00253
• Device Sequence Number: 6021377
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2023

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: 04/01/2025
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C12W
• Device Lot Number: 0000276663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 08/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOONS
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 58 KG