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	09/21/2021
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 id: (b)(4), it was reported that: procedure information procedure date: (b)(6) 2021 procedure type: peripheral runoff what condition was the patient being treated for?: pad what was the outcome of the procedure?: procedure completed successfully description of the event patient complications: no patient complications description of the event: tech indicated upon opening the package with the guide wire that they noticed the wire appeared to be defective.They opened another wire but it appeared to be damaged as well.Finally opened a wire from another box.Additional information received 5 oct 2021: 1.Could you further describe the damaged noted on the wire (i.E peeled coating, kink, flattened, etc)? it appears the distal portion / piece of wire is coming apart.
Additional Manufacturer Narrative
Device evaluation added.
Event or Problem Description
Per salesforce complaint id: (b)(4), it was reported that: procedure information procedure date: (b)(6) 2021.Procedure type: peripheral runoff what condition was the patient being treated for?: pad.What was the outcome of the procedure?: procedure completed successfully description of the event patient complications: no patient complications.Description of the event: tech indicated upon opening the package with the guide wire that they noticed the wire appeared to be defective.They opened another wire but it appeared to be damaged as well.Finally opened a wire from another box.Additional information received 5 oct 2021: 1.Could you further describe the damaged noted on the wire (i.E peeled coating, kink, flattened, etc)? it appears the distal portion / piece of wire is coming apart.

• Brand Name: STARTER GUIDEWIRE
• Common Device Name: GUIDEWIRE
• MDR Report Key: 12651981
• Report Number: 9681477-2021-00017
• Device Sequence Number: 11123561
• Product Code: DQX
• UDI-Device Identifier: 08714729743149
• UDI-Public: (01)08714729743149(17)240430(10)6317001
• 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: 6317001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Initial Date Received by Manufacturer: 09/23/2021
• 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