MAUDE Adverse Event Report: TERUMO CLINICAL SUPPLY CO., LTD. PRIORITY ONE AC; ASPIRATION THROMBECTOMY CATHETER

Model Number	N/A
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported injury to a patient in the catheterization lab for a non-stemi, where an attempt was made to aspirate a clot.Using a right radial approach with a 6f guide ebu, a percutaneous coronary intervention (pci) with a 2.5mm balloon was performed.The priority one catheter crossed, and the clot was aspirated.However, as the catheter was being withdrawn from the third diagonal, resistance was encountered, and additional force used to remove it caused the tip on p1 to dislodge and remain inside the coronary artery.The patient was stable but was transferred to the for further intervention, which was not performed as the patient remained stable.The procedure conducted was a heart catheterization, with no blood loss reported.The patient has a history of chest pain.

• Brand Name: PRIORITY ONE AC
• Common Device Name: ASPIRATION THROMBECTOMY CATHETER
• Manufacturer (Section D): TERUMO CLINICAL SUPPLY CO., LTD.; 3 kawashima-takehayamachi; kakamigahara; gifu, 501-6 024; JA 501-6024
• MDR Report Key: 19581991
• Report Number: 2243441-2024-00019
• Device Sequence Number: 11645202
• Product Code: QEZ
• UDI-Device Identifier: 04987350779373
• UDI-Public: 04987350779373
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2024
• Report Date (Section F): 06/16/2024

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: 09/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 25-1011
• Device Lot Number: 231031Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/15/2024
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/21/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2024
• 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: .014 MANMO WIRE BSC; 2.5MM PCI BALLOON; 6F GLIDE SHEATH; 6F MEDTRONIC WBU CORONARY GUIDE CATH
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 06/16/2024