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

Model Number	N/A
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the involved destination ex guiding sheath was used in evt for a diffuse lesion from l-cfa to sfa.The guiding sheath was delivered up to the lesion via retrograde approach without problems.A guidewire was then inserted into the guiding sheath, but resistance was felt.When the guiding sheath was removed from the patient, a kink was noted in the guiding sheath.The guiding sheath was not used and was replaced with another guiding sheath, which was used without kinking.Subsequently, the procedure was successfully completed.No health damages.Estimated blood loss was less 250cc's.
Additional Manufacturer Narrative
A review of the device history record of the product code/lot# combination was conducted with no findings.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 no.1 to provide the completed investigation results.The actual device has been returned for evaluation.One tr band was returned to terumo medical corporation for evaluation.The sample was subject to visual analysis.No visual damage or defects were noted on the balloons or band.There is 3.5 ml of air left in the balloon assembly.The sample was subject to leak testing.Approximately 18 ml of air was injected into the balloon assembly and submerged in a water bath for approximately 30 seconds.Air bubbles were observed from the seal around the inflation balloon and check valve.The sample failed leak testing.The sample was placed under the microscope to get a better look at the location of the leak.Upon visual analysis there is a gap in the seal between the inflation balloon and check valve.The complaint can be confirmed for air leakage issues.The cause is a gap on the check valve to inflation balloon seal.The operations quality engineer was notified, and non-conformances (nc) was initiated for this issue.Nc will contain root cause analysis and corrective actions.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: 17717161
• Report Number: 1118880-2023-00401
• Device Sequence Number: 17930516
• Product Code: DYB
• UDI-Device Identifier: 00389701009414
• UDI-Public: 00389701009414
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2025
• Device Model Number: N/A
• Device Catalogue Number: 54-84501
• Device Lot Number: 0000308407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CATHETERS
• Patient Sex: Unknown