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

Model Number	H74939706JPNS0
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This medwatch report is being filed based on the image received on december 14, 2023.The image presented an unknown length of fractured material.The remaining length of the guidewire is not visible in the image.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 described in the warnings (dfu): · prior to use, inspect for damage.If damaged, do not use.As described in the preparation for use: · safari2tm guidewires should be handled carefully and inspected before 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.At this time, it is not possible to assign a definitive root cause for the event as reported.Patient information was not provided.If there is any further relevant information provided, a follow up medwatch report will be submitted.
Event or Problem Description
Event description: per cnf, it was reported that: event; shaping; no the coating was peeled off, and the device was difficult to cross; therefore, it was replaced.No patient injury.Additional information received 24dec2023: the issue occurred at outside body during preparation.When the device was unpacking, the physician visually confirms that the coating on the wire on the opposite side of the part to be inserted into the patient has peeled off.
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: 18425905
• Report Number: 2126666-2024-00001
• Device Sequence Number: 7856777
• Product Code: DQX
• UDI-Device Identifier: 00816349012327
• UDI-Public: (01)00816349012327(17)260717(10)8531784
• 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,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 Expiration Date: 07/17/2026
• Device Model Number: H74939706JPNS0
• Device Catalogue Number: H74939706JPNS0
• Device Lot Number: 8531784
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2023
• 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