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	07/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.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.
Event or Problem Description
The user facility reported that upon prep of the product, the physician noted that the valve would not tighten.It seemed to "roll back" or loosen automatically.A second sheath was opened and used.This second sheath appeared to tighten when in contact with blood but ultimately was not completely secure.There was no blood loss.There is not direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.Additional information was received on 31 jul 2023: the procedure performed prior to using the device was a cardiac catheterization.The patient was stable.The procedure was completed using the second device.The procedure was successful.There were additional devices used with the second device.A sequence of catheters was used to engage the coronary arteries that were delivered through this sheath.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section h3, and to provide the completed investigation results.One r2p sheath and dilator were returned for product assessment.The sample was subject to visual analysis.There is no damage or deformities on the sheath or dilator.The valve is engaged and tightened (see attached photos).The components of the valve were inspected to check for damage.No damage was found on the grooves or screw of the valve.The sample was subject to functional testing.The valve was tightened and loosened multiple times.There were no issues with keeping the valve tightened.The sample was placed under constant pressure leak testing.No leaks were observed from the valve.The complaint cannot be confirmed for the valve loosening during use.The exact root cause cannot be determined.The likely root cause is the valve was not completely tightened during preparation for the procedure, leading to it loosening during use.Review of the 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: 17623220
• Report Number: 1118880-2023-00378
• Device Sequence Number: 12648589
• Product Code: DYB
• UDI-Device Identifier: 00389701012360
• UDI-Public: 00389701012360
• 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): 08/25/2023

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: 06/01/2024
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C75W
• Device Lot Number: 0000126696
• 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: 09/12/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 10/12/2023
• 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