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	06/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Event description: when inserting the safari2 xs wire, there was damage to the end of the wire.A new wire was used.What troubleshooting steps, if any, resolved the issue?: use a new safarixs wire patient present at time of event?: yes.Patient complications: no patient complications question: are any patient status updates available? answer: no patient harm.Question: what were possible contributing factors (comorbidities etc)? answer: damage during unpacking.Question: when specifically during device prep or during the procedure did the device damage occur? answer: start of the procedure.
Additional Manufacturer Narrative
This medwatch report is being filed based on the product evaluation, which revealed fractured core wire material.As received, the specimen consisted of one-1 each safari2 275cm xsml crv; returned coiled, loose and 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 specimen presented a core wire fracture at 275 cm from the distal aspect of the formed curve with subsequent stretched coil damage.The specimen also presented kink/bend damage of the coil at 0.6cm from the proximal end.It should be noted that this product undergoes a 100% non-destructive machine pull/proof test to verify weld integrity as part of the lot release inspection and testing.The distal joint appears to be correct and intact by visual examination and by non-destructive testing.The information in the event description does not mention the safari2 guidewire being fractured near the proximal end; therefore, the exact timing of the damage cannot be determined at this time.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 described in the device 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.As described in the device instructions for use (dfu) warnings: · exercise care in handling of the guidewire during a procedure to reduce the possibility if accidental breakage, bending, kinking or coil separation.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 procedural and/or handling factors have contributed to the event as reported.The patient information was not provided.If there is any further relevant information provided, a follow up medwatch report will be submitted.

• 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: 17565811
• Report Number: 2126666-2023-00052
• Device Sequence Number: 6665259
• Product Code: DQX
• UDI-Device Identifier: 08714729887614
• UDI-Public: 08714729887614
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/17/2023

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: 01/08/2026
• Device Model Number: H74939406XS1
• Device Catalogue Number: 39406XS
• Device Lot Number: 7505481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2023
• 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