MAUDE Adverse Event Report: ABBOTT MEDICAL INTRODUCER FASTCATH; INTRODUCER, CATHETER

Model Number	CVD0022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Vascular Problem (4441)
Date of Event	08/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a procedure the fast-cath 5fr sheath was noted to be flimsy and the inner part of the sheath was too long.The transition from the inner to the sheath itself was not tapered enough.The sheath damaged the blood vessel.The procedure was successfully completed and the patient is stable.
Additional Manufacturer Narrative
Model/lot number information was not able to be obtained for this device.Therefore, full udi information(d4) and 510k(g3) are not available.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: INTRODUCER FASTCATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23052586
• Report Number: 3005334138-2025-00553
• Device Sequence Number: 13177927
• Product Code: DYB
• UDI-Device Identifier: 05414734023412
• UDI-Public: 05414734023412
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: CVD0022
• Device Catalogue Number: CVD0022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown