MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION R2P¿ DESTINATION SLENDER¿ GUIDING SHEATH

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687); Swelling/ Edema (4577)
Date of Event	09/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: age & date of birth: requested, not provided.A3: patient sex: requested, not provided.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: lab manager.A review of the device history record of the product code/lot # combination was conducted with no finding.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.
Event or Problem Description
The user facility reported that the involved device sheath was removed without the dilator but over the wire.Felt the sheath tug a little so thought there was a spasm and as it was pulled it started to shred.Then the doctor came and pulled it out and it frayed off and was left behind.The doctor thought that the frayed piece was all out of the radial artery.However, the patient was in the hospital and left and within 12 hours came back to hospital with swelling in the arm.The patient was taken to the operating room and the vascular surgeon (va) removed a couple mm of metal left behind from the sheath.Thrombectomy of the right radial and brachial.Patient outcome and arm is now stable.The patient was still in patient care in the hospital but due to a respiratory failure unrelated to the incident.The event occurred intra-operative.The estimated blood loss was less than 250cc's.There is a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.
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for assessment.Without a sample, the exact root cause cannot be determined.The likely root cause is the sheath was withdrawn during a patient spasm and due to the increased resistance, the sheath separated.Review of device history record (dhr) showed there were no issues noted during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: 18157008
• Report Number: 1118880-2023-00430
• Device Sequence Number: 8045889
• Product Code: DYB
• UDI-Device Identifier: 00389701012377
• UDI-Public: 00389701012377
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 11/16/2023

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: 02/01/2026
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C85W
• Device Lot Number: 0000393413
• 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: 10/17/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown