MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED STARTER GUIDEWIRE

Model Number	M001491181
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for analysis.As reported by the customer: 'unusable, kinked guidewire.The ward doctor noticed the problem when inserting the guide.There was a hitch, it was not going through.The guidewire would have broken at the "j" shape extremity level.This is a recurring problem, this is the 4th occurrence, all guidewires from the same batch.Noted consequences: the procedure time was lengthened.'' 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 lake region medical and was determined to be acceptable.At this time it is not possible to assign a definitive root cause for the event as reported.Based on the information provided by the supporting documentation, "excessive force used", "improper use", "improper handling", "user failure in preparations for use" and/or "improper removal from packaging" may have impacted on the event as reported.
Event or Problem Description
Unusable, kinked guidewire.The ward doctor noticed the problem when inserting the guide.There was a hitch, it was not going through.The guidewire would have broken at the "j" shape extremity level.This is a recurring problem, this is the 4th occurrence, all guidewires from the same batch.Noted consequences: the procedure time was lengthened.
Event or Problem Description
Unusable, kinked guidewire.The ward doctor noticed the problem when inserting the guide.There was a hitch, it was not going through.The guidewire would have broken at the "j" shape extremity level.This is a recurring problem, this is the 4th occurrence, all guidewires from the same batch.Noted consequences: the procedure time was lengthened.
Additional Manufacturer Narrative
Device evaluation completed.

• 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: 10799797
• Report Number: 9681477-2020-00018
• Device Sequence Number: 3841227
• Product Code: DQX
• UDI-Device Identifier: 08714729743040
• UDI-Public: (01)08714729743040(17)230731(10)5911056
• 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
• Report Date (Section B): 12/21/2020

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: 07/31/2023
• Device Model Number: M001491181
• Device Lot Number: 5911056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1