MAUDE Adverse Event Report: CORDIS CORPORATION SGW STAB PLUS .014 300CM J SS; WIRE, GUIDE, CATHETER

Model Number	507114Y
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the distal area of a.014 stabilizer plus 300cm j-curve supersoft guidewire was already frayed before it was even manipulated.So, because of this situation it was necessary to open another unknown guidewire to continue the procedure.There was no reported patient injury.The device will be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 35262966 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the distal area of a.014 stabilizer plus 300cm j-curve supersoft guidewire was frayed before it was manipulated.Because of this situation it was necessary to open another unknown guidewire to continue the procedure.There was no reported patient injury.The product was not returned for analysis.A product history record (phr) review of lot 35262966 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-wires- frayed/split/torn¿ could not be confirmed.Handling factors such as pulling the distal tip to remove the guidewire from the dispenser 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, ¿open the sterile package slowly.To prevent damage to the distal tip of the guidewire and to prevent the guidewire from springing onto a non-sterile field, carefully remove the guidewire from the dispensing tube.Use the dispenser window to advance the guidewire distal tip, such that the guidewire can be removed by grasping the coated shaft.Note: 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.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the distal area of a.014 stabilizer plus 300cm j-curve supersoft guidewire was already frayed before it was even manipulated.Another unknown guidewire was used to continue the procedure.There was no reported patient injury.A non-sterile guidewire ¿sgw stab plus.014 300cm j ss¿ was received for analysis.The unit was visually inspected, and the radiopaque distal coil wire was noted to be unraveled.No other damages or anomalies were observed on the returned unit.The distal tip was analyzed using a vision system to magnify the damaged area.The coil wire presents with an unraveled condition, which exposed the core wire.A product history record (phr) review of lot 35262966 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The failure reported by the customer as ¿distal tip-wires~ frayed/split/torn¿ was not confirmed.However, the tip of the guidewire was noted to be unraveled/stretched.The exact cause of these damages could not be conclusively determined during the analysis.Handling factors such as pulling the distal tip to remove the guidewire from the dispensing tube 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, ¿guidewires are delicate instruments and should be handled carefully.Prior to use and when possible, during the procedure, inspect the guidewire carefully for coil separation, bends, or kinks.Do not use a guidewire that shows signs of damage.To prevent damage to the distal tip of the guidewire and to prevent the guidewire from springing onto a non-sterile field, carefully remove the guidewire from the dispensing tube.Use the dispenser window to advance the guidewire distal tip, such that the guidewire can be removed by grasping the coated shaft.Note: 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.

• Brand Name: SGW STAB PLUS .014 300CM J SS
• 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 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15321868
• Report Number: 1016427-2022-05417
• Device Sequence Number: 5227236
• Product Code: DQX
• UDI-Device Identifier: 10705032056168
• UDI-Public: (01)10705032056168(17)230228(10)35262966
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K873403
• 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,Followup
• Report Date (Section B): 10/26/2022

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: 02/28/2023
• Device Model Number: 507114Y
• Device Catalogue Number: 507114Y
• Device Lot Number: 35262966
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2022
• Supplement Date Received by Manufacturer: 09/02/2022; 10/07/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 09/06/2022; 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2021
• 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: UNKNOWN GUIDEWIRE.
• Patient Sex: Unknown