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

Model Number	N/A
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.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 during a splenic artery aneurysm, the physician was trying to remove an undeployed.018" via bahn and felt resistance, and the patient experienced pain.He applied nitro paste and carefully removed the entire system (sheath, via bahn and.018" wire).The sheath was visibly kinked.Hemostasis was achieved with the tr band.There was no surgical intervention required.The patient was stable.The treatment of splenic artery aneurysm procedure outcome was unsuccessful, however was not related to the sheath.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One r2p slender guiding sheath was returned for product evaluation.The returned product included the sheath.The sample was subjected to visual analysis.There was 42.3cm of a via bahn sticking out from the r2p sheath and 139.6cm guidewire was sticking out from the proximal end of the via bahn.18.2cm of guidewire was sticking out from the r2p sheath tip.There was compression from 5.9cm to 7.6cm, 19.7cm to 33.6cm, 37.8cm to 38.1cm, 42.5cm to 42.7cm, 53.1cm to 53.4cm, 55.7cm to 56.2cm, 58.0cm to 58.5cm, 60.7cm to 61.0cm, 63.2cm to 65.8cm.A kink was also found on the sheath 65.0cm.Swage band on the r2p hub was properly placed and there was no damage to the sheath tip.The complaint can be confirmed for sheath mechanical damage.The exact root cause cannot be determined.The likely root cause is the r2p sheath faced resistance during insertion or tracking to the target anatomy.Review of the 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 failure mode & effects analysis (fmea).

• 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: 14541322
• Report Number: 1118880-2022-00037
• Device Sequence Number: 12456072
• Product Code: DYB
• UDI-Device Identifier: 00389701012384
• UDI-Public: 00389701012384
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 05/30/2022

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: 09/01/2023
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C95W
• Device Lot Number: 0000040276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 05/30/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2021
• 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: GORE .018" VIA BAHN REF. VBJR0610002A; NITRO PASTE; TR BAND
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic