MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED STARTER GUIDEWIRE

Model Number	M001491211
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
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
It was reported that: -dossier : mv 21-0540 difficulty in progressing with the guide in the humeral artery.When it is released, the sheath was severed.-clinical consequences observed : second surgical approach.
Additional Manufacturer Narrative
Distributor confirmed device not available for return.
Event or Problem Description
It was reported that: dossier: mv 21-0540 difficulty in progressing with the guide in the humeral artery.When it is released, the sheath was severed.Clinical consequences observed: second surgical approach.
Additional Manufacturer Narrative
Updated with device evaluation.
Event or Problem Description
It was reported that: -dossier : mv 21-0540 difficulty in progressing with the guide in the humeral artery.When it is released, the sheath was severed.-clinical consequences observed : second surgical approach.

• Brand Name: STARTER GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): LAKE REGION MEDICAL LIMITED; butlersland; new ross; co. wexford, Y34 K 825; EI Y34 K825
• Manufacturer (Section G): LAKE REGION MEDICAL LIMITED; butlersland; new ross; co. wexford, Y34 K 825; EI Y34 K825
• Manufacturer Contact: suzanne foley ; butlersland; new ross; co. wexford, Y34 K-825 ; EI Y34 K825
• MDR Report Key: 12923262
• Report Number: 9681477-2021-00021
• Device Sequence Number: 5615582
• Product Code: DQX
• UDI-Device Identifier: 08714729743071
• UDI-Public: (01)08714729743071(17)240831(10)6512321
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: M001491211
• Device Lot Number: 6512321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 12/17/2021; 02/15/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 12/27/2021; 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown