MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED BENTSON TYPE PTFE COATED GUIDEWIRE

Model Number	M0066201000
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product is expected to be returned to lake region medical for evaluation.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.
Event or Problem Description
When scrub tech removed wire from the plastic tube the flexible tip was detached from the wire.Pulled another of the same wire and completed the case.Device issues or patient complications? only device performance issue(s).
Event or Problem Description
When scrub tech removed wire from the plastic tube the flexible tip was detached from the wire.Pulled another of the same wire and completed the case.Device issues or patient complications? only device performance issue(s).
Additional Manufacturer Narrative
H6 medical device problem code should have been changed from 1260 to 2976 in fu1 report.
Additional Manufacturer Narrative
Incorrect model / lot number reported in initial report d4 and h4 amended.Device evaluation completed.The software would not allow me to add a health effect - impact code.Appropriate coding from the resources is no health consequences or impact (2199).
Event or Problem Description
When scrub tech removed wire from the plastic tube the flexible tip was detached from the wire.Pulled another of the same wire and completed the case.Device issues or patient complications? only device performance issue(s).

• Brand Name: BENTSON TYPE PTFE COATED 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: 10465087
• Report Number: 9681477-2020-00009
• Device Sequence Number: 19555690
• Product Code: DQX
• UDI-Device Identifier: 08714729056676
• UDI-Public: (01)08714729056676(17)240131(10)5646713
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/19/2020

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: 05/31/2024
• Device Model Number: M0066201000
• Device Catalogue Number: 620-120
• Device Lot Number: 5746976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 09/01/2020; 09/01/2020
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 09/10/2020; 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1