MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION DESTINATION; INTRODUCER, CATHETER

Model Number	RSR01
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	09/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the procedure performed was a percutaneous transluminal angioplasty (pta) via femoral access.Punction was performed by seldinger technique and insertion of a lunderquist guide wire was done.When advancing the rsr01 the dilator entered the vessel without resistance, when advancing the sheath into the vessel resistance was felt.The tip of the sheath seemed to roll up due to the resistance.The patient condition was stable and there was no harm to the patient.Additional information was received on 01oct2024: a 6 french procedure sheath was used.There were no issues with arterial access, sheath, guidewire, or catheter insertion.It was unknown if a pre-deployment angiogram was performed.There were no issues with insertion, deployment, or withdrawal of the device.Hemostasis was achieved by the angio-seal.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided due to privacy rules.A2: age & date of birth: requested, not provided due to privacy rules.A3a: sex: requested, not provided due to privacy rules.A3b: gender: requested, not provided due to privacy rules.A4: weight: requested, not provided due to privacy rules.A5: ethnicity: requested, not provided due to privacy rules.A6: race: requested, not provided due to privacy rules.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.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.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.One 6 french destination sheath with its dilator fully inserted was returned for evaluation.The tip of the sheath was visually assessed.It was deformed with the tip crinkled inwards and fraying at the tip edge.The complaint can be confirmed for deformation of the sheath tip based on the condition of returned device.The exact root cause could not be determined.Historically, deformations of the sheath tip occur during insertion, as the destination sheath tip is atraumatic and designed to prevent damage to the artery if faced with resistance.Review of 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 hazard based risk table (hbrt).

• Brand Name: DESTINATION
• 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 ; 4103927218
• MDR Report Key: 20417046
• Report Number: 1118880-2024-00152
• Device Sequence Number: 8304038
• Product Code: DYB
• UDI-Device Identifier: 00389701006161
• UDI-Public: (01)00389701006161(17)261001(10)0000561013
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K172995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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: 10/01/2026
• Device Model Number: RSR01
• Device Catalogue Number: RSR01
• Device Lot Number: 0000561013
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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: LUNDERQUIST GUIDE
• Patient Sex: Unknown