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

Model Number	H74939406XS0
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not received at the time of this report; therefore, no physical or visual analysis could be completed.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 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 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.As indicated in the operational instructions preparation for use: verify compatibility of interacting devices prior to use.Care should be taken when advancing a guidewire after device deployment.The wire should only be introduced into or withdrawn from the ventricle through a catheter already positioned in the ventricle.The curve of the safari2¿ guidewire should be constrained within a catheter during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, it appears that procedural and/or clinical factors may have impacted on the event as reported.The patient information is unknown.If there is any further relevant information, a follow up medwatch report will be submitted.
Event or Problem Description
Event description: after release from a navitor it was not possible to switch the safari in any direction.The safari wire had to be pulled with the complete delivery catheter out of the patient.The procedure was completed successfully.What troubleshooting steps, if any, resolved the issue?: they pulled the whole system including the wire out of the patient.Patient present at time of event?: yes.Patient complications: no patient complications.Question: are any patient status updates available? answer: patient outcome good.Additional information received 15mar2024: question: what does it mean, "it was not possible to switch the safari in any direction"? answer: the guidewire stuck inside the delivery catheter, was not possible to pull it out, neither outside of the patient.Question: what was the reason for the safari guidewire having to be pulled with the complete delivery catheter out of the patient? answer: the guidewire stuck inside the delivery catheter, was not possible to pull it out, neither outside of the patient.Question: is the guidewire stuck inside the delivery catheter? answer: the guidewire stuck inside the delivery catheter, was not possible to pull it out, neither outside of the patient.Question: if so, were the devices able to be separated once outside the patient? answer: the guidewire stuck inside the delivery catheter, was not possible to pull it out, neither outside of the patient.Question: was the valve implanted successfully? answer: yes.Question: was there any intervention required? answer: no.Question: were any additional devices required to complete the procedure? answer: no.Question: the safari2 ifu states, "verify compatibility of interacting devices prior to use".Did the end user test the devices for compatibility prior to use? answer: yes.Question: in the end users opinion, what was the cause of the event? answer: do not know.Question: was there any damage noted to the guidewire upon removal from the patient? answer: do not know.
Additional Manufacturer Narrative
Device evaluation: as received, the specimen consisted of one-1 each pkg-safari2 275cm x sml crv 5p; returned still lodged within the delivery system, 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 offset/overlapping coil wraps in the distal region extending distally from the delivery system.The specimen also presented kink damage at 146.4cm and 150.2cm from the proximal aspect of the formed curve.The specimen wire is firmly lodged within the delivery system, preventing its removal for further examination.The damage presented by the specimen appeared consistent with manipulation of the wire against resistance.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 device instructions for use warnings: · do not torque this wire.· 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 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.As indicated in the operational instructions preparation for use: · verify compatibility of interacting devices prior to use.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided, it appears that procedural and/or clinical factors have impacted on the event as reported.If any further relevant information is received, a follow up medwatch report will be submitted.
Additional Manufacturer Narrative
Correction to a previously submitted mdr to correct the brand name in section d1 and the model number, catalog number and primary unique device identifier (udi) number in section d4.

• 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: 18932502
• Report Number: 2126666-2024-00022
• Device Sequence Number: 4580452
• Product Code: DQX
• UDI-Device Identifier: 08714729887621
• UDI-Public: (01)08714729887621(17)261115(10)8476984
• 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,Followup,Followup
• Report Date (Section B): 06/24/2024

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 Model Number: H74939406XS0
• Device Catalogue Number: H74939406XS0
• Device Lot Number: 8476984
• 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: 03/05/2024
• Supplement Date Received by Manufacturer: 03/05/2024; Not provided
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/15/2024; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2023
• 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