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

Model Number	H74939406S1
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This medwatch report is being filed based on images received on february 22, 2022, which present a fracture of the core wire.The device was not received for analysis at the time of this report; therefore, no physical analysis of the product could be performed.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 supplied images presented a fracture of the core wire and stretched coil wraps in the distal tip extending proximally from the j-straightener/introducer.As described in the device instructions for use (dfu): ensure a catheter is properly placed in the ventricle or other intended treatment area.Carefully remove the safari2tm guidewire from the hoop by grasping the proximal end of the j-straightener separating the straightener from the hoop.After inspection of the safari2tm guidewire, advance the j-straightener over the distal section of the safari2tm guidewire to straighten the curve.Insert the safari2tm guidewire into the hub of the catheter with the aid of the j-straightener.Carefully advance the distal tip of the safari2tm guidewire into the lumen of the catheter.Remove the safari2tm guidewire j-straightener by withdrawing it over the length of the safari2tm guidewire.Advance the safari2tm guidewire through the catheter under fluoroscopic guidance.As indicated in the dfu warnings: "do not torque this guidewire." at this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided to date, it appears that clinical and/or procedural factors may have impacted on the event as reported.If any further relevant information is provided, a follow up medwatch report will be submitted.
Event or Problem Description
The wire was inserted into the introducer in the groin, so was inside the patient at the time of the event, but may or may not have had vessel wall contact.No vascular damage noted and the wire was removed and a new wire from the same lot was used to complete the procedure.No patient complications.Was issue present upon opening package?: no.Photo or video of issue: yes.Question: are any patient status updates available? answer: no.Question: describe anatomy (bicuspid, gothic arch, acute bend, horizonal aorta, degree of curvature etc)? answer: normal anatomy.Question: is it known what caused the device damage? answer: unknown.Question: where specifically on the device did the damage occur? answer: when the j-straightener was pulled back the wire uncoiled.Additional information provided via email on february 23, 2022: you note that the wire was inserted in the introducer in the groin.With this in mind, when exactly was this damage noticed upon insertion? the damage to the wire was noted when the j-straightener was pulled back , this after a few cm of insertion of the wire.A.At what point in the procedure was the safari2 removed from the patient? the damaged safari wire was removed during the initial period of the procedure where access to the groin vessels have been obtained with 6-8 fr.Introducers.
Additional Manufacturer Narrative
Device evaluation: as received, the specimen consisted of one-1 each safari2 275cm sml crv; returned coiled, loose with the distal tip lodged within the j-straightener and double-bagged within "zip-lock" style poly biohazard pouches.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 ductile, tensile overload of the core wire an unknown distance from the distal tip weld mass with concurrent stretched coil damage; the distal tip is lodged within the lumen the j-straightener attachment 3.40cm from the distal tip of the j-straightener.Approximately 1.80cm of the metallic core wire proximal of the fracture is protruding through the coil wraps.The exposed core wire presented bend damage 0.60 to 0.754cm from the proximal aspect of the wire fracture.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 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.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided to date, it appears that handling and/or procedural factors have contributed to the event as reported.If any further relevant information is received, 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: 13688838
• Report Number: 2126666-2022-00013
• Device Sequence Number: 1945010
• Product Code: DQX
• UDI-Device Identifier: 08714729887591
• UDI-Public: 08714729887591
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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,Followup
• Report Date (Section B): 03/30/2022

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: 10/24/2024
• Device Model Number: H74939406S1
• Device Catalogue Number: 39406S
• Device Lot Number: 6618383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2021
• 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 Age: 84 YR
• Patient Sex: Male