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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: requested, not provided.Date of birth: requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: materials management.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 r2p device involved was kinked and broken.Additional information was received on (b)(6) 2022: after the destination slender was removed from the patient, it was noted that the distal portion of the sheath was kinked and broken.The device either broke during procedure or during removal.It was noted that the sheath was pulled out of patient, but there were no issues removing the sheath.Once removed from the patient, there were no issues inside the body.The procedure was completed successfully.The patient was in stable condition.There was no blood loss.Uncertain it is related to the break, the lab noted there was a steep iliac bifurcation.There were no devices or other products used with the above product.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.2 to update section , and to provide the completed investigation results.One r2p destination slender was returned for product evaluation.The returned sample included is the sheath.The sample was subjected to visual analysis.There was a kink found 29.3cm from the sheath hub.The site of the kink was inspected under a microscope and the coil was found to have torn through the pebax outer layer.The coil also appeared to be broken.The complaint can be confirmed for mechanical separation.The exact root cause cannot be determined.The likely root cause is the sheath was kinked during the procedure and the kinking led to the eventual breakage.Review of device history record (dhr) review 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 failure mode and effects analysis (fmea).
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 to provide the device return date in section d9.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.

• 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: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 14521085
• Report Number: 1118880-2022-00041
• Device Sequence Number: 14854088
• Product Code: DYB
• UDI-Device Identifier: 00389701012384
• UDI-Public: 00389701012384
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2022

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: 01/01/2024
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C95W
• Device Lot Number: 0000055943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2022
• Supplement Date Received by Manufacturer: 05/27/2022; 06/28/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 06/22/2022; 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2021
• 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
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White