MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED STARTER GUIDEWIRE

Model Number	M001491181
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.Awaiting device return for further analysis.
Event or Problem Description
Per salesforce complaint id: (b)(4), it was reported that: time of event: during preparation procedure information procedure date: asked, but not available as per account/customer.Procedure type: unknown what condition was the patient being treated for?: unknown what was the outcome of the procedure?: unknown clinical study information related to a clinical study?: no description of the event device issues or patient complications? only device performance issue(s) description of the event: correct upn m001491380.Account requested to return for credit: (4) box of same lot number.What troubleshooting steps took place? na what troubleshooting steps, if any, resolved the issue? what is the next course of action? used different wire products product ? starter guidewire, 0.035"/180cm/j3 upn: 8749212 lot/serial number: (b)(4) was the device implanted or did an attempt to implant occur?: no failure modes related to this device include: break/fractured were the issues present upon opening the package?: no indicate any attached/related device(s): the account has requested to return for credit (4) boxes of this lot number.Gfe questions [starter guidewire, 0.035"/180cm/j3] what is the plan for this patient? (e.G.Monitor, planned intervention, etc.).
Additional Manufacturer Narrative
Udi corrected in d4.Updated as device not available for return.
Event or Problem Description
Per salesforce complaint id: (b)(4), it was reported that: time of event: during preparation procedure information procedure date: asked, but not available as per account/customer.Procedure type: unknown what condition was the patient being treated for?: unknown what was the outcome of the procedure?: unknown clinical study information related to a clinical study?: no description of the event device issues or patient complications? only device performance issue(s) description of the event: correct upn m001491380.Account requested to return for credit: (4) box of same lot number.What troubleshooting steps took place? na what troubleshooting steps, if any, resolved the issue? what is the next course of action? used different wire products product? starter guidewire, 0.035"/180cm/j3 upn: 8749212 lot/serial number: (b)(6) was the device implanted or did an attempt to implant occur?: no failure modes related to this device include: break/fractured were the issues present upon opening the package?: no indicate any attached/related device(s): the account has requested to return for credit (4) boxes of this lot number.Gfe questions [starter guidewire, 0.035"/180cm/j3] what is the plan for this patient? (e.G.Monitor, planned intervention, etc.).

• 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: 12074275
• Report Number: 9681477-2021-00011
• Device Sequence Number: 4154606
• Product Code: DQX
• UDI-Device Identifier: 08714729743330
• UDI-Public: (01)08714729743330(17)231130(10)5999760
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2021

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: 10/31/2023
• Device Model Number: M001491181
• Device Lot Number: 5980322
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1