MAUDE Adverse Event Report: STARTER GUIDEWIRE

Model Number	M001491341
Medical Device Problem Codes	Fracture (1260); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records for the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.
Event or Problem Description
Per salesforce complaint (b)(4), it was reported that: patient complications: no patient complications description of the event: wire appeared to be damaged upon taking the wire out of the hoop.There appeared to be a separation of the wire at the distal tip.
Additional Manufacturer Narrative
Device evaluation added.
Event or Problem Description
Per salesforce complaint id: (b)(4), it was reported that: patient complications: no patient complications description of the event: wire appeared to be damaged upon taking the wire out of the hoop.There appeared to be a separation of the wire at the distal tip.

• Brand Name: STARTER GUIDEWIRE
• Common Device Name: GUIDEWIRE
• MDR Report Key: 12652174
• Report Number: 9681477-2021-00018
• Device Sequence Number: 1443157
• Product Code: DQX
• UDI-Device Identifier: 08714729743149
• UDI-Public: (01)08714729743149(17)240430(10)6285993
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K935170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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: 04/30/2024
• Device Model Number: M001491341
• Device Lot Number: 6285993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2021
• 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