MAUDE Adverse Event Report: LAKE REGION MEDICAL FORTE GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	H74934949070
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not received for evaluation; therefore, no physical or visual 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.As described in the device instructions for use (dfu), precaution, "exercise care in handling of the guidewire during a procedure to reduce the possibility of accidental breakage, bending, kinking or coil separation.Do not use a guidewire that has been damaged.Do not attempt to straighten a wire that has been kinked or bent.Do not advance a kinked guidewire into a balloon catheter or guide catheter to reduce the potential of wire breakage." at this time, it is not possible to assign a definitive root cause for the event as reported.The patient information was not provided.If any further relevant information is provided, a follow up medwatch report will be submitted.
Event or Problem Description
Event description: it was told to me that the operator jail stented the coronary wire behind the stent and when removing the forte wire from behind the stent, the distal portion of the wire was stripped off of the wire core and was left in the patients artery distal to the stent.Patient is stable without deficits.What troubleshooting steps, if any, resolved the issue?: removal of jailed wire what is the next course of action?: leave portion of wire in patient complications: no patient complications additional information received on 03oct2023: the forte wire was the jailed coronary wire.No picture.The wire was left where it was, behind the stent.They could not retrieve.Yes fluoroscopy was used.Yes there was resistance.It was behind the deployed stent.

• Brand Name: FORTE GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: 17939778
• Report Number: 2126666-2023-00070
• Device Sequence Number: 12375726
• Product Code: DQX
• UDI-Device Identifier: 08714729286721
• UDI-Public: 08714729286721
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K011968
• 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): 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: H74934949070
• Device Catalogue Number: 3494907
• Device Lot Number: 7461318
• 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: 09/29/2023
• Initial Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown