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

Model Number	RSR04
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
7f destination renal guiding sheath (45cm ref- rsr04 lot0000484177 exp 7/1/2026) inserted into right femoral artery.Penumbra lightning bolt 7 (indigo system 7f 130cm ref - litngbt7tq130 lot h00004313 exp 1/1/2027) inserted through destination sheath (mentioned above) for placement in the left lower extremity (lle) artery.During use, the surgeon noted he was unable to advance the catheter.Imaging was taken and md noted a kink in the catheter and sheath.Md attempted to advance a wire through catheter but was unsuccessful.While attempting to remove the catheter and sheath, both devices broke into two pieces (four total).All pieces successfully extracted.

• Brand Name: DESTINATION
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 20385148
• Report Number: 20385148
• Device Sequence Number: 6567047
• Product Code: DYB
• UDI-Device Identifier: 00389701006192
• UDI-Public: (01)00389701006192(17)280701(10)0000484177
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2024
• Report Date (Section F): 07/02/2024

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 Model Number: RSR04
• Device Catalogue Number: RSR04
• Device Lot Number: 0000484177
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/07/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Date Report Sent to FDA: 07/02/2024