MAUDE Adverse Event Report: LAKE REGION MEDICAL SAFARI2¿; WIRE, GUIDE

Model Number	H74939407S0
Medical Device Problem Codes	Entrapment of Device (1212); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not received at the time of this report; therefore, no physical or visual 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.As indicated in the device instructions for use, operational instructions, preparation for use: inspect and prepare the catheter according to the manufacturer's instructions.This includes flushing the catheter to be used with heparinized saline solution.Verify compatibility of interacting devices prior to use.As indicated in the device instructions for use warnings: exercise care in handling of the guidewire during a procedure to reduce the possibility of accidental breakage, bending, kinking or coil separation.Resulting guidewire fractures might require additional percutaneous intervention or surgery.Never advance the guidewire against the resistance without first determining the reason for resistance under fluoroscopy.Excessive force against resistance may result in damage to the catheter or vessel/organ.Care should be taken when advancing a guidewire after device deployment.The wire should only be introduced into or withdrawn from the ventricle through a catheter already positioned in the ventricle.The curve of the safari2¿ guidewire should be constrained within a catheter during insertion into or withdrawal from the body or treatment site.At this time, it is not possible to assign a definitive root cause for the event as reported.If any further relevant information is received, a follow up medwatch report will be submitted.
Event or Problem Description
It was reported that: during the procedure the body and the end of the guide were peeled.Consequence: need to remove the guide together with the release system (evolut pro+).No consequences for the patient.
Additional Manufacturer Narrative
Section h6 medical device problem code revised.Additionally, section h11 has been updated to report that product is not expected to be returned.The device is not expected to be returned for analysis; therefore, no physical or visual analysis 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.As indicated in the device instructions for use, operational instructions, preparation for use: · inspect and prepare the catheter according to the manufacturer's instructions.This includes flushing the catheter to be used with heparinized saline solution.· verify compatibility of interacting devices prior to use.As indicated in the device instructions for use warnings: · exercise care in handling of the guidewire during a procedure to reduce the possibility of accidental breakage, bending, kinking or coil separation.Resulting guidewire fractures might require additional percutaneous intervention or surgery.· never advance the guidewire against the resistance without first determining the reason for resistance under fluoroscopy.Excessive force against resistance may result in damage to the catheter or vessel/organ.Care should be taken when advancing a guidewire after device deployment.· the wire should only be introduced into or withdrawn from the ventricle through a catheter already positioned in the ventricle.· the curve of the safari2¿ guidewire should be constrained within a catheter during insertion into or withdrawal from the body or treatment site.At this time, it is not possible to assign a definitive root cause for the event as reported.If any further relevant information is provided, a follow up medwatch report will be submitted.
Additional Manufacturer Narrative
This medwatch report is an update to the previous report to correct the brand name in section d1 and the catalog number and primary unique device identifier (udi) number in section d4.Additionally, product was received for evaluation on june 17, 2024; therefore, sections d9, h2, h3,h6, and h11 have been updated to account for the device evaluation.Device evaluation: as received, the specimen consisted of one-1 each pkg-safari2 275cm sml crv 1pk; returned coiled, loose without the dispenser assembly; double bagged within "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 ductile, tensile overload of the core wire at 0.2cm from the distal tip weld mass with approximately 12.5cm of concurrent stretched coil damage beginning at the distal tip.The specimen also presented kink damage at 11.2cm from the proximal aspect of the formed curve along with stretched coil damage at 167.7cm.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, operational instructions, preparation for use: · inspect and prepare the catheter according to the manufacturer's instructions.This includes flushing the catheter to be used with heparinized saline solution.· verify compatibility of interacting devices prior to use.As indicated in the device instructions for use warnings: · exercise care in handling of the guidewire during a procedure to reduce the possibility of accidental breakage, bending, kinking or coil separation.Resulting guidewire fractures might require additional percutaneous intervention or surgery.· never advance the guidewire against the resistance without first determining the reason for resistance under fluoroscopy.Excessive force against resistance may result in damage to the catheter or vessel/organ.Care should be taken when advancing a guidewire after device deployment.· the wire should only be introduced into or withdrawn from the ventricle through a catheter already positioned in the ventricle.· the curve of the safari2¿ guidewire should be constrained within a catheter during insertion into or withdrawal from the body or treatment site.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 and/or handling factors have contributed to the event as reported.If any further relevant information is provided, a follow up medwatch report will be submitted.

• Brand Name: 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: 18740250
• Report Number: 2126666-2024-00012
• Device Sequence Number: 17952698
• Product Code: DQX
• UDI-Device Identifier: 08714729887652
• UDI-Public: (01)08714729887652(17)260911(10)8256726
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2024

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: 09/11/2026
• Device Model Number: H74939407S0
• Device Catalogue Number: H74939407S0
• Device Lot Number: 8256726
• 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: 01/29/2024
• Supplement Date Received by Manufacturer: 01/29/2024; Not provided
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 03/20/2024; 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2023
• 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