MAUDE Adverse Event Report: NIPRO MEDICAL INDUSTRIES (NMI) AQUALINER SUPER ELASTIC HYDROPHYLLIC GUIDEWIRE

Model Number	ALS+35260AS
Medical Device Problem Codes	Material Fragmentation (1261); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Partial amounts of the guidewire coating separated inside the vessel during patient procedure.According to facility patient is ok.There was a package wrapper with the wire (lot#22j03) but it was never confirmed if this was indeed the lot number of the damaged wire.

• Brand Name: AQUALINER SUPER ELASTIC HYDROPHYLLIC GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): NIPRO MEDICAL INDUSTRIES (NMI); 2-19-64, matsubara; tatebayashi-shi, gunma 374-8 518; JA 374-8518
• MDR Report Key: 19744486
• Report Number: 1056186-2024-00012
• Device Sequence Number: 11685269
• Product Code: DQX
• UDI-Device Identifier: 00383790006255
• UDI-Public: 00383790006255
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 07/15/2024
• Report Date (Section F): 07/15/2024

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: ALS+35260AS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/14/2024
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/15/2024