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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: requested, not provided; age & date of birth: requested, not provided; patient sex: requested, not provided; weight: requested, not provided; ethnicity: requested, not provided; race: requested, not provided; date of event: requested, not provided; implanted date: device was not implanted; explanted date: device was not explanted ;initial reporter occupation: unknown purchasing.The actual device has not 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 the tip of the destination r2p device involved came off while attempting to insert it into the artery.The procedure was a pacemaker insertion case.There is not a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.
Additional Manufacturer Narrative
A review of the device history record of the product code and lot number combination was conducted with no findings related to the reported event.One r2p sheath and dilator were returned to terumo medical corporation for assessment.The sample was subject to visual analysis.The dilator is not inserted into the sheath.The sheath does not have any bends, kinks, or deformations.The sheath measures 118.9 centimeters (cm) in length.The dilator is broken 127.8 cm from the dilator hub.The broken piece is 0.4 cm in length.No other damage was noted on the dilator.The complaint can be confirmed for separation of the dilator and dilator tip.The exact root cause cannot be determined.It is possible the user experienced resistance during insertion of the dilator and during withdraw the dilator tip broke.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 ; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 16539270
• Report Number: 1118880-2023-00022
• Device Sequence Number: 6471770
• Product Code: DYB
• UDI-Device Identifier: 00389701011547
• UDI-Public: 00389701011547
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 03/14/2023

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: 11/01/2024
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C12W
• Device Lot Number: 0000177910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2023
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2022
• 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
• Patient Sex: Unknown