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

Model Number	H74939706JPNXS1
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This medwatch report is being filed based on a review of images provided on february 01, 2022 and the results of the device evaluation, both exhibiting a core wire fracture.The supplied images presented stretched coil damage with stretched coil still loaded through the j-straightener/introducer and exposed metallic core wire with fracture, and a portion of the coil still lodged in a dispenser clip retained by the anti-migration device.As received, the specimen consisted of one-1 each safari2 jpn 275cm x sml crv; returned coiled, loose with the stretched coil still loaded through the j-straightener/introducer and double-bagged within "zip-lock" style poly biohazard pouches.The remainder of the dispenser assembly was not returned with the specimen device.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 fracture of the proximal end of the core wire and stretched coil wraps from 20.80 distal of the proximal end joint to 31.3cm from the proximal end of the core wire.After obtaining permission, the coil wraps adjacent to the proximal joint were stretched to reveal a tensile overload of the proximal coil to core wire joint immediately adjacent to the weld mass.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.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 procedural factors have contributed to the event as reported.The patient information was not 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: damage is there any appearance abnormality before use? yes.Please describe in detail where and what kind of abnormality was found in the complaint content column.There is a high possibility that the film had peeled off and it could not be properly done.Where and what kind of damage was observed; unknown.

• 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
• MDR Report Key: 13548481
• Report Number: 2126666-2022-00011
• Device Sequence Number: 12026765
• Product Code: DQX
• UDI-Device Identifier: 10816349012331
• UDI-Public: 10816349012331
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/17/2022

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: 06/13/2024
• Device Model Number: H74939706JPNXS1
• Device Catalogue Number: 4939706JPNXS
• Device Lot Number: 6418197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2021
• 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