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	01/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The coil has broken.- tip of wire already slightly bent (during preparation), wire in patient and guide catheter not to be advanced over the broken coil (during procedure), for which to change the wire.- wire has been in patient - successfully closed procedure - no other complications.Additional information reported that the procedure was completed with exchange of a new wire from the box.No patient complications.Patient fully recovered.
Additional Manufacturer Narrative
This medwatch report is being filed based on the image received on (b)(6) 2022, which appears to present a fracture of the metallic core wire.The device was not received for evaluation at the time of this report; therefore, no physical analysis of the device 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 image appears to present a fracture of the metallic core wire an unknown distance from the distal tip weld with an indeterminate length of the metallic core wire proximal of the fracture protruding through the outer coil was; consistent with tensile loading.The exposed core wire proximal of the fracture presents several kinks consistent with column strength overload; consistent with advancing the wire against resistance.As noted in the event description, "the coil has broken.- tip of wire already slightly bent (during preparation), wire in patient".This observation indicated the end user was aware of the damage and elected to use the damaged device in spite of the warnings and instructions noted in the dfu.As described in the device instructions for use (dfu): as indicated in the dfu warnings: prior to use, inspect for damage.If damaged, do not use.Do not torque this guidewire.Exercise care in handling of the guidewire during a procedure to reduce the possibility of accidental breakage, bending, kinking, or coil separation.Never advance the guidewire against resistance without first determining the reason for resistance under fluoroscopy.Preparation for use: ·safari2tm guidewires should be handled carefully and inspected prior to use and when possible during the procedure to observe for any defect or damage that may occur.Do not use a wire that has a damaged coating, tip, camber (change in plane), bend or kink on the wire.Damage will hinder the performance of the safari2tm guidewire.Prior to use and when possible during the procedure, inspect the guidewire carefully for coil separation, bends, or kinks which may have occurred.Do not use a wire which has a damaged tip.Damage will hinder the performance of the guidewire.Instructions for use: 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 appears that procedural factors have impacted on 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.
Additional Manufacturer Narrative
Device evaluation: as received, the specimen consisted of one-1 each safari2 275cm sml crv; returned coiled, loose 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 0.35cm from the distal tip with bending loads and subsequent coil stretching exposing the metallic core wire approximately 11cm from the distal tip and kink/bend damage over the 0.75cm proximal of the core wire fracture and 84.1 to 84.3cm from the distal aspect of the formed curve.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 noted in the event description, "the coil has broken.- tip of wire already slightly bent (during preparation), wire in patient".This observation indicated the end user was aware of the damage and elected to use the damaged device in spite of warnings and instructions noted in the dfu.As described in the device instructions for use (dfu): as indicated in the dfu warnings: prior to use, inspect for damage.If damaged, do not use.Do not torque this guidewire.Exercise care in handling of the guidewire during a procedure to reduce the possibility of accidental breakage, bending, kinking, or coil separation.Never advance the guidewire against resistance without first determining the reason for resistance under fluoroscopy.Preparation for use: ·safari2tm guidewires should be handled carefully and inspected prior to use and when possible during the procedure to observe for any defect or damage that may occur.Do not use a wire that has a damaged coating, tip, camber (change in plane), bend or kink on the wire.Damage will hinder the performance of the safari2tm guidewire.Prior to use and when possible during the procedure, inspect the guidewire carefully for coil separation, bends, or kinks which may have occurred.Do not use a wire which has a damaged tip.Damage will hinder the performance of the guidewire.Instructions for use: 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.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 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
• MDR Report Key: 13684856
• Report Number: 2126666-2022-00014
• Device Sequence Number: 1868946
• Product Code: DQX
• UDI-Device Identifier: 08714729887591
• UDI-Public: 08714729887591
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2022

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: 09/19/2024
• Device Model Number: H74939406S1
• Device Catalogue Number: 39406S
• Device Lot Number: 6550711
• 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: 02/24/2022
• Supplement Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 03/07/2022
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• 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