MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED STARTER GUIDEWIRE

Model Number	M001492251
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records of 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 (b)(6) medical and was determined to be acceptable.
Event or Problem Description
It was reported that: the j point of the guide is kinking and the body breaks.Where did the problem occur? outside the patient.Action taken by the physician to try to resolve the event: none.Was the problem associated with labeled use? yes.Event resolved? yes.
Additional Manufacturer Narrative
Device evaluation and update to codes.
Event or Problem Description
It was reported that: the j point of the guide is kinking and the body breaks where did the problem occur? outside the patient action taken by the physician to try to resolve the event: none was the problem associated with labeled use? yes event resolved? yes.

• 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
• MDR Report Key: 9097789
• Report Number: 9681477-2019-00012
• Device Sequence Number: 2664533
• Product Code: DQX
• UDI-Device Identifier: 08714729743682
• UDI-Public: 08714729743682
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K935170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2019

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: 02/28/2022
• Device Model Number: M001492251
• Device Catalogue Number: 49-225
• Device Lot Number: 4730501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1