MAUDE Adverse Event Report: CORDIS CORPORATION PGW .018 SV SHORT 300CM ST; WIRE, GUIDE, CATHETER

Model Number	503558X
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the distal tip of an sv-5 0.018 300cm guidewire frays easily while being maneuvered and loses its characteristics.As a result, a non-cordis.014 guidewire was used as a replacement.There was no reported injury to the patient.This was during a procedure to treat a 50% stenosed lesion in the superficial femoral artery (sfa) which had mild calcification but no tortuosity.This was during a procedure to treat a 50% stenosed lesion in the superficial femoral artery (sfa) which had mild calcification but no tortuosity.There were no acute angles or bifurcations present at the target lesion.The device was stored, handled, and prepped per the instructions for use (ifu) and there was nothing unusual about the device prior to use.There was never an attempt to shape the distal tip of the guidewire and the guidewire was manipulated under fluoroscopy.The device was able to be removed easily and remained in one piece during its removal.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b3, d4, d8, d9, g3, g4, g6, h1, h2, h3, h6, and h10.Complaint conclusion: as reported, the distal tip of an sv-5 0.018 300cm guidewire frays easily while being maneuvered and loses its characteristics.As a result, a non-cordis.014 guidewire was used as a replacement.There was no reported injury to the patient.This was during a procedure to treat a 50% stenosed lesion in the superficial femoral artery (sfa) which had mild calcification but no tortuosity.There were no acute angles or bifurcations present at the target lesion.The device was stored, handled, and prepped per the instructions for use (ifu) and there was nothing unusual about the device prior to use.There was never an attempt to shape the distal tip of the guidewire and the guidewire was manipulated under fluoroscopy.The device was able to be removed easily and remained in one piece during its removal.The product was not returned for analysis.A product history record (phr) review of lot 35265672 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device or images for analysis, the reported customer event ¿distal tip-frayed/split/torn¿ could not be confirmed.Patient vessel characteristics and/or handling factors may have contributed to the reported event.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿never advance, withdraw or auger the guidewire against resistance without first determining the cause of resistance under fluoroscopy.Torquing the guidewire against resistance may cause damage and/or fracture which may result in separation of the distal tip.Do not pull the distal tip to remove guidewire from dispenser as it may damage the tip.¿ based on the information available and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.
Event or Problem Description
As reported, the distal tip of an sv-5 0.018 300cm guidewire frays easily while being maneuvered and loses its characteristics.As a result, a non-cordis.014 guidewire was used as a replacement.There was no reported injury to the patient.This was during a procedure to treat a 50% stenosed lesion in the superficial femoral artery (sfa) which had mild calcification but no tortuosity.This was during a procedure to treat a 50% stenosed lesion in the superficial femoral artery (sfa) which had mild calcification but no tortuosity.There were no acute angles or bifurcations present at the target lesion.The device was stored, handled, and prepped per the instructions for use (ifu) and there was nothing unusual about the device prior to use.There was never an attempt to shape the distal tip of the guidewire and the guidewire was manipulated under fluoroscopy.The device was able to be removed easily and remained in one piece during its removal.The device was not returned as expected.

• Brand Name: PGW .018 SV SHORT 300CM ST
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 16414379
• Report Number: 1016427-2023-05439
• Device Sequence Number: 3289813
• Product Code: DQX
• UDI-Device Identifier: 10705032056069
• UDI-Public: (01)10705032056069(17)240531(10)35265672
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K930091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2023

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: 05/31/2024
• Device Model Number: 503558X
• Device Catalogue Number: 503558X
• Device Lot Number: 35265672
• 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: 01/27/2023
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 03/16/2023
• Date Device Manufactured: 06/03/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ABBOTT COMMAND 14 GUIDEWIRE
• Patient Sex: Unknown