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

Model Number	N/A
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Serious Injury
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.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.For this reason, investigation conclusions code has been referenced.A review of the device history record of the product code/lot# combination was conducted with no findings.
Event or Problem Description
The user facility reported that the neurosurgeon accessed the right radial artery for a arteriovenous fistula (davf) embolization from the left enlarged vestibular aqueduct (eva) branches.He stated that he could not get access to the vessels of interest without a diagnostic catheter in place.When he was able to get to the vessel of interest the slender destination device kinked and injured the microcatheter and wire.He had to pull out the slender destination sheath and used a different sheath, from a different company, and it worked.He stated he does not believe it was anatomical.The patient was stable, and the procedure outcome was successful.The estimated blood loss was less than 250cc.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information in section b5, to update section h3, and to provide the completed investigation results.One 95cm 6fr r2p destination sheath was returned for product evaluation.Visual inspection revealed that the sheath had a major kink at 78.8cm from the sheath hub.There was minor damage noted at the sheath tip, the tip was slightly deformed.No damage other damage was noted on the device.The exact cause of the event cannot be determined; however, it is possible that transverse and torsional forces during usage of the device caused the failure.It cannot be confirmed if the insertion difficulty was due to the patient's anatomy or handling of the device during use.The device was in a conforming state when released from terumo control.There is no indication that any manufacturing issues may have led to this event.Currently no action is recommended since this risk evaluation is within the predetermined limits in the fmea.
Event or Problem Description
Additional information was received on 18may2021.The dilator was in place when the sheath was inserted and was in place when the physician was attempting to reach the access site.The physician used a 5/6 glidesheath slender to access.

• Brand Name: R2P DESTINATION SLENDER GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 11676393
• Report Number: 1118880-2021-00076
• Device Sequence Number: 19620423
• Product Code: DYB
• UDI-Device Identifier: 00389701012384
• UDI-Public: 00389701012384
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C95W
• Device Lot Number: YF13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GLIDESHEATH SLENDER
• Outcome Attributed to Adverse Event: Required Intervention