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

Model Number	H74934949020
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not received for evaluation at the time of this report; 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 noted in the device instructions for use (dfu) precautions, "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." 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 clinical and/or procedural factors may have impacted on the event as reported.The patient information was not provided at the time of this report.If any further relevant information is provided, a follow up medwatch report will be submitted.
Event or Problem Description
Description of the event: wire was directed down the pda.A 2.0x12mm balloon was advanced.The balloon would get the distal end of the wire and not move any further.After several attempts of trying the get the balloon down the balloon became stuck on the distal end of the wire.The wire and balloon were removed in one piece.The balloon was forcibly removed from the wire.A 300cm pilot 50 was used to rewire the lesion.The balloon was reinserted and inflated as it should have originally.No patient complications reported.The procedure was completed successfully.Additional information reported that the wire was damaged and the balloon would not go further and became stuck.
Additional Manufacturer Narrative
Device evaluation: 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 3.85 to 4.55cm from the distal tip, creating localized oversized diameters to 0.1700".The specimen also presented several bends located 0.25 to 2.00cm, and 213.5 to 218.8cm from the distal tip.The coil and bend damage over the distal 4.55cm 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 noted in the device instructions for use (dfu) precautions, "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." 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 clinical and/or procedural factors may have impacted on the event as reported.If any further relevant information is provided, a follow up medwatch report will be submitted.

• Brand Name: FORTE GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 12225093
• Report Number: 2126666-2021-00030
• Device Sequence Number: 19897364
• Product Code: DQX
• UDI-Device Identifier: 08714729286677
• UDI-Public: 08714729286677
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,Followup
• Report Date (Section B): 08/03/2021

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: 03/31/2024
• Device Model Number: H74934949020
• Device Catalogue Number: 3494902
• Device Lot Number: 6239954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 07/26/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1