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

Model Number	GS-R6ST1C75W
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Foreign Body In Patient (2687)
Date of Event	09/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that they had an aortic stenosis pressure gradient procedure.The operator advanced the initial 6fr glidesheath slender into the radial artery then swapped for a 75cm destination slender.Advanced pigtail past the aortic valve to take simultaneous pressures.Once finished, they went ahead and tried to remove the sheath without dilator.Radial spasm occurred and operator tried to sedate patient, administered nitro and additional cocktails, put under general anesthesia however, no luck in relieving the spasm.After two hours the sheath seemed to move a bit, and they tried to pull it out.Sheath pulled out but stainless-steel coils remained inside the body.The patient was sent to surgery for cut-down removal.They did not measure the radial artery going in and turned out to be a tortuous high radial brachial take-off where the sheath seemed to have kinked and got stuck.The surgery was successful.Additional information was received on 16sept2024: the patient was doing fine, and blood loss was less than 250cc.
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: requested, not provided due to hospital policy.A6: race: requested, not provided due to hospital policy.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: clinical coordinator.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.
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 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 attempted to be removed in the face of resistance due to tortuosity in the artery and vascular spasm.Additionally, the dilator was not reinserted during removal which can assist with withdrawal of the sheath.The r2p instructions for use (ifu) was reviewed, and it states: "caution: while inserting or withdrawing, if resistance is met, do not advance or withdraw the sheath until the cause of resistance has been determined." review of the device history record (dhr) showed there were no issues noted during the 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 hazard based risk table (hbrt).

• 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: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 20360814
• Report Number: 1118880-2024-00148
• Device Sequence Number: 8059019
• Product Code: DYB
• UDI-Device Identifier: 00389701012360
• UDI-Public: (01)00389701012360(17)261101(10)0000598132
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/03/2024

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 Model Number: GS-R6ST1C75W
• Device Catalogue Number: GS-R6ST1C75W
• Device Lot Number: 0000598132
• 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: 09/03/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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: .035" GLIDEWIRE; 6FR GLIDESHEATH SLENDER; 75CM SHEATH
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown