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	06/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: not available due to hospital policy.Age & date of birth: not available due to hospital policy.Weight: not available due to hospital policy.Ethnicity: not available due to hospital policy.Race: not available due to hospital policy.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: field clinical specialist.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 radial procedure, the physician was unable to pass a 6fr catheter through the destination slender product.The procedure was diagnostic only, the catheter did not perform as expected.The patient was not injured during the event and medical or surgical intervention was not required.The procedure outcome was completed successfully.There was no reported blood loss.The event occurred intra-operative.Additional information was received on 15 jun 2023: they were not able to get the 6fr cath (penumbra neuro sheath) to pass through the guiding sheath slender.They removed the catheter, and a 5fr sheath was passed up into the head.The patient was in stable condition.
Additional Manufacturer Narrative
This report is being sent as follow-up #1 to update section h3, and to provide the completed investigation results.One r2p sheath and dilator with a penumbra 6fr catheter were returned to for evaluation.The sample was subject to visual analysis.There is no damage or deformities on the sheath or dilator.The dilator is not inserted into the sheath.The penumbra catheter is partially inserted into the sheath and will not advance.The penumbra catheter was removed, and the dilator was fully inserted into the sheath without resistance.The sample was subject to functional testing.The sheath tip and hub inner diameter (id) was measured, and the max allowance was 0.086" which is within specification.The penumbra catheter outer diameter (od) was measured to be 0.0757-0.0874".The complaint cannot be confirmed for mobility issues with the sheath because the sheath is within specification and no damage or deformities were noted on the sheath.The exact cause is the penumbra catheter used with the sheath is larger than the industry standard for 6fr catheters, preventing the catheter from advancing.Penumbra was contacted about the catheter.Review of device history record (dhr) showed there were no issues noted during the 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: 17244602
• Report Number: 1118880-2023-00289
• Device Sequence Number: 14661210
• Product Code: DYB
• UDI-Device Identifier: 00389701012384
• UDI-Public: 00389701012384
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 07/02/2023

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: 09/01/2025
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C95W
• Device Lot Number: 0000329829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 07/02/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: .035 GWA; 4/5 SLENDER SHEATH; PENUMBRA NEURO; TR BAND
• Patient Sex: Male