MAUDE Adverse Event Report: CORDIS CORPORATION PGW .018 SV SHORT 180CM ST; WIRE, GUIDE, CATHETER

Model Number	503558
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a sv steerable guidewire.018 180cm was used and it unraveled during the procedure.There was no reported patient injury.The wire unraveled inside the patient.The device was not resterilized.The wire was not removed from the dispenser by the distal floppy end.The wire was not kinked or damaged in any way prior to insertion into the patient.The wire was not re-shaped by the user.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.Addendum: product evaluation presents fractured/separated condition in the core wire noted to be separated into two pieces.
Additional Manufacturer Narrative
As reported, an sv steerable guidewire.018 180cm was used and it unraveled during the procedure.There was no reported patient injury.The wire unraveled inside the patient.The device was not resterilized.The wire was not removed from the dispenser by the distal floppy end.The wire was not kinked or damaged in any way prior to insertion into the patient.The wire was not re-shaped by the user.A non-sterile guidewire ¿pgw.018 sv short 180cm st¿ was returned for analysis.During visual inspection, the radiopaque distal coil wire was noted to be unraveled.The distal tip of the wire was analyzed using a vision system to magnify the damaged area.The proximal tip of the coil wire is attached to the core wire presenting an unraveled condition that caused the exposure of the core wire.The coil wire does not present any separation.The core wire section that is inside of the coil wire is fractured/separated in two parts.The separated section of the core wire was returned attached to the distal end of the coil wire.Sem analysis presented evidence of a fractured/separated condition with the core wire noted to be separated into two pieces.The separated portions of the core wire were returned for analysis and the fractured/separated areas of the core wire presented evidence of plastic deformation and striations on the damaged areas of the unit.A product history record (phr) review of lot 35263424 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The failures reported by the customer as ¿guidewire ~ unraveled/stretched¿ and ¿distal tip-wires ~ fractured/separated¿ were confirmed.The wire is unraveled and a separation of the core wire was observed.Plastic deformations are commonly associated with separations caused by material tensile overload therefore, it is assumed the wire was induced to a tensile force that exceeded its material yield strength prior to the separation.Exact cause of the damages noticed on the guidewire could not be conclusively determined during the analysis.Vessel characteristics or manipulating the guidewire against resistance 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.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 use a guidewire that shows signs of damage.Tip fractures have been reported in procedures involving total occlusions, highly tortuous vasculature, and small side branches.Do not pull the distal tip to remove guidewire from dispenser as it may damage the tip.Gently introduce and advance the guidewire to prevent damaging the distal 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: PGW .018 SV SHORT 180CM 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: 15538533
• Report Number: 1016427-2022-05425
• Device Sequence Number: 17660761
• Product Code: DQX
• UDI-Device Identifier: 10705032056052
• UDI-Public: 10705032056052
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2022

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: 05/31/2023
• Device Model Number: 503558
• Device Catalogue Number: 503558
• Device Lot Number: 35263424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2021
• 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
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 80 KG