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

Model Number	H74939706JPNS1
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was reported to have been disposed; therefore, no physical analysis of the device can 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 warnings: monitor wire position throughout the procedure for proper placement of the curve and distal tip.When advancing or removing the guidewire, always use fluoroscopic guidance with radiographic equipment that provides high-resolution images.Never position the guidewire blindly, as this may result in misplacement, dissection or perforation.Never advance the guidewire against resistance without first determining the reason for resistance.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 impacted on the event as reported.The patient information was not provided at the time of this report.If there is any further relevant information provided, a follow up medwatch report will be submitted.
Event or Problem Description
This device was delivered, and an elolute r was placed.There was a resistance when the device was removed, and it could not be removed at first.A jr imaging catheter was inserted, and this device was successfully removed.When the device was confirmed outside the body, a tissue was attached at the coil part of the tip.When a pathological analysis was performed, it was reported that it was a part of the chordae tendineae and mitral valve.Procedure was completed without replacing the device and such (an issue occurred, but target treatment was completed.) there was no report of serious injury and no adverse patient effects.

• Brand Name: PREFORM GUIDEWIRE-SAFARI2
• Common Device Name: WIRE GUIDE
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 11946959
• Report Number: 2126666-2021-00017
• Device Sequence Number: 4179404
• Product Code: DQX
• UDI-Device Identifier: 10816349012324
• UDI-Public: 10816349012324
• 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
• Report Date (Section B): 06/07/2021

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: 06/23/2023
• Device Model Number: H74939706JPNS1
• Device Catalogue Number: 39706JPNS
• Device Lot Number: 5870024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1