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

Model Number	N/A
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Pain (1994); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	05/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4: weight: 58.6 kilograms.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: vascular surgeon.The actual device was not available for returned; therefore, an evaluation of the actual device will not be conducted.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 involved 6fr 119cm destination slender was placed in right radial artery and was advanced all the way to the level of the common femoral artery without issue.The patient did receive a radical anti-spasmodic cocktail.The superficial femoral artery (sfa) intervention was completed.During removal of the sheath, the physician experienced extreme resistance, and the patient had extreme discomfort.There was an additional spasmodic cocktail administered along with additional pain medication.The physician waited and then begin to remove the sheath again.The physician once again felt extreme resistance and the sheath tore.The patient was taken immediately to the operating room for removal of the sheath that was still implanted.The event occurred intra-operative.Patient was in stable condition.Additional information was received on 07 jun 2023: patient did not have particularly tortuous anatomy.There was no direct allegation against the device from the clinician, that it caused or contributed to the event.It has been confirmed that there was a spasm that occurred during the removal of the sheath.
Event or Problem Description
Additional information was received on 07 jun 2023: patient did not have particularly tortuous anatomy.There is no direct allegation against the device from the clinician, that it caused or contributed to the event.It was confirmed that the spasm occurred during the removal of the sheath.Terumo medical received an fda medwatch report mw# 5118842.The event description stated that the patient had an outpatient angioplasty procedure.During the procedure and after placement of stents, the wire and sheath were difficult to pull.Medications were given to relax the vessels.The sheath separated and a portion remained requiring transfer to operating room for removal.
Additional Manufacturer Narrative
This report is being sent as follow-up # 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 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: 17244084
• Report Number: 1118880-2023-00326
• Device Sequence Number: 14767434
• Product Code: DYB
• UDI-Device Identifier: 00389701012384
• UDI-Public: 00389701012384
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2023

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: 08/01/2022
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C12W
• Device Lot Number: 0000327163
• 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: 05/31/2023
• Supplement Date Received by Manufacturer: 07/24/2023; 07/30/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/11/2023; 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2023
• 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: MISAGO AND CROSSTELLA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White