MAUDE Adverse Event Report: LAKE REGION MEDICAL PREFORM GUIDEWIRE - SAFARI2; WIRE, GUIDE

Model Number	H74939406XS1
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This medwatch report is being filed based on an image received from the distributor on july 11, 2023, revealing fractured material.As received, the specimen consisted of one-1 each safari2 275cm xsml crv in 2 separate pieces accompanied by 2 unknown devices.The distal portion of the returned specimen was still lodged in the unknown device along with white thread like material.The proximal portion of the returned specimen was received loose; double bagged with in "zip-lock" style poly biohazard pouch.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.During manufacturing and packaging of this product the operators are instructed to 100% visually inspect for any obvious defect prior to shipment.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The distal portion of the specimen presented stretched coil wire material lodged within the unknown device.The proximal portion of the returned specimen presented the fracture of the core and coil wire with indications of shear cut damage of the core towards the proximal end.The nature and the extent of the damage indicated that the guidewire was manipulated against the resistance.There was no mention of wire entrapment or fracture/shear damaged or need to cut the guidewire to remove it in the information provided to date.Therefore, the timing of the wire entrapment and damage cannot be determined.Our investigation was unable to confirm that the product did not meet specification prior to shipment.The investigation concluded that the product met specification at the time of shipment.As indicated in the dfu, instructions for use (dfu): 1.Ensure a catheter is properly placed in the ventricle or other intended treatment area.2.Carefully remove the safari2tm guidewire from the hoop by grasping the proximal end of the j-straightener separating the straightener from the hoop.3.After inspection of the safari2tm guidewire, advance the j-straightener over the distal section of the safari2tm guidewire to straighten the curve.4.Insert the safari2tm guidewire into the hub of the catheter with the aid of the j-straightener.5.Carefully advance the distal tip of the safari2tm guidewire into the lumen of the catheter.6.Remove the safari2tm guidewire j-straightener by withdrawing it over the length of the safari2tm guidewire.7.Advance the safari2tm guidewire through the catheter under fluoroscopic guidance.8.Confirm safari2tm guidewire curve position to assure safari2tm guidewire placement and stability.9.Maintain wire position while tracking or advancing a catheter or device over the wire.10.To remove the guidewire from the treatment area: a.A catheter must be advanced into the treatment area over the safari2tm guidewire prior to withdrawing the wire.B.The safari2tm guidewire is pulled back completely into the catheter.C.The safari2tm guidewire may then be withdrawn from the catheter.11.When finished with the procedure, dispose of guidewire by using standard methods used in a hospital environment.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided and the evidence presented, it appeared that handling and/or clinical factors have contributed to the event as reported.No patient information was provided at the time of this report.If any further relevant information is received, a follow up medwatch report will be submitted.
Event or Problem Description
Event description: guide wire was reported to the coordinator as having unraveled.The wire was removed and replaced with a lunderquist wire to use for the procedure.What troubleshooting steps, if any, resolved the issue?: the device was removed.What is the next course of action?: removed for lunderquist.Patient present at time of event?: yes.Patient complications: no patient complications.

• Brand Name: PREFORM GUIDEWIRE - SAFARI2
• Common Device Name: WIRE, GUIDE
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: sharon seifert ; 340 lake hazeltine drive; chaska, MN 55318 ; 9526418518
• MDR Report Key: 17392099
• Report Number: 2126666-2023-00047
• Device Sequence Number: 21054101
• Product Code: DQX
• UDI-Device Identifier: 08714729887614
• UDI-Public: 08714729887614
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K151244
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2023

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: 04/09/2026
• Device Model Number: H74939406XS1
• Device Catalogue Number: 39406XS
• Device Lot Number: 7595108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown