MAUDE Adverse Event Report: BRIVANT LIMITED AXIMED PRIME SOFT SHAPEABLE TIP VASCULAR GUIDEWIRE

Model Number	901017-09-AXI
Medical Device Problem Codes	Failure to Advance (2524); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the prime wire was too tacky, too much drag by time came out of distal end it could not be used.Dr.Singh is a repeat user and had good experience with 0.18 wire.
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
It was reported that the prime wire was too tacky, too much drag by time came out of distal end it could not be used.Dr.Singh is a repeat user and had good experience with 0.18 wire.
Event or Problem Description
It was reported that the prime wire was too tacky, too much drag by time came out of distal end it could not be used.Dr.Singh is a repeat user and had good experience with 0.18 wire.
Additional Manufacturer Narrative
This report represents a correction to align with gudid.Change in brand name from : aximed 0.014" * 180cm to aximed prime soft shapeable tip vascular guidewire change of company name from: lake region medical to brivant limited.

• Brand Name: AXIMED PRIME SOFT SHAPEABLE TIP VASCULAR GUIDEWIRE
• Common Device Name: AXIMED PRIME SOFT SHAPEABLE TIP VASCULAR GUIDEWIRE
• Manufacturer (Section D): BRIVANT LIMITED; parkmore west business park; galway; galway, H91CK 22,; EI H91CK22,
• Manufacturer (Section G): BRIVANT LIMITED; brivant limited; parkmore west business park; galway, H91CK 22; EI H91CK22
• Manufacturer Contact: amy carter ; parkmore west business park; galway, H91 C-K22 ; EI H91 CK22
• MDR Report Key: 18101841
• Report Number: 3006010712-2023-00057
• Device Sequence Number: 20845861
• Product Code: DQX
• UDI-Device Identifier: 00860009941328
• UDI-Public: 00860009941328
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K122856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2024

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: 06/30/2026
• Device Model Number: 901017-09-AXI
• Device Catalogue Number: AXPMST-200-14
• Device Lot Number: 8542274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2023
• Supplement Date Received by Manufacturer: 10/31/2023; 10/31/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 01/31/2024; 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2023
• 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