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.
Additional Manufacturer Narrative
When the rep picked up the actual sample there was a package wrapper (individual packaging) with the guidewire with lot 22j03, but it was never confirmed that this was indeed the lot number in question.
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.
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.
Additional Manufacturer Narrative
When the rep picked up the actual sample there was a package wrapper (inidivual packaging) with the guidewire with lot 22j03, but it was never confirmed that this was indeed the lot number in question.

• 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
• Manufacturer (Section G): NIPRO MEDICAL INDUSTRIES (NMI); 2-19-64, matsubara; tatebayashi-shi, gunma 374-8 518; JA 374-8518
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 19744835
• Report Number: 9611446-2024-00001
• Device Sequence Number: 6579374
• Product Code: DQX
• UDI-Device Identifier: 00383790006255
• UDI-Public: 00383790006255
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K001251
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2024

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 06/17/2024; 06/17/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 07/30/2024; 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown