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

Model Number	503658X
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, when the physician was using a 0.018" 300cm straight (st) tip sv peripheral steerable guidewire (pgw) for a right heart catheterization, the wire seemed to be catching when trying to remove it from a non-non-cordis swanz ganz catheter.Upon removal the wire was unraveled.There was no reported patient injury or complications.The product was stored as per labeling.The device was being used in a right heart catheterization using a femoral approach.The device was not being used for a chronic total occlusion.There were no anomalies noted when the product was removed from the package.The product was inspected and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.There was no damage noticed to the device prior to opening the package nor difficulty removing the device from the sterile packaging.The other devices used did not show any signs of damage after the procedure; just the the distal end of the wire was unraveled.No excess force was used during the procedure.Product evaluation revealed the guidewire is fractured.
Additional Manufacturer Narrative
Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.The device was received for analysis but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, when the physician was using a 0.018" 300cm straight (st) tip sv peripheral steerable guidewire (pgw) for a right heart catheterization, the wire seemed to be catching when trying to remove it from a non-non-cordis swanz ganz catheter.Upon removal the wire was unraveled.There was no reported patient injury or complications.The product was stored as per labeling.The device was being used in a right heart catheterization using a femoral approach.The device was not being used for a chronic total occlusion.There were no anomalies noted when the product was removed from the package.The product was inspected and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.There was no damage noticed to the device prior to opening the package nor difficulty removing the device from the sterile packaging.The other devices used did not show any signs of damage after the procedure; just the distal end of the wire was unraveled.No excess force was used during the procedure.A non-sterile guidewire ¿pgw.018 sv inter 300cm st¿ was for analysis.The radiopaque distal coil wire was noted to be unraveled during visual inspection.No other damages or anomalies were observed on the returned unit.Dimensional analysis was performed to verify the outer diameter of the guidewire body.Measurements were taken at the proximal, middle, and distal sections to be verified with the specification printed on the label product.The results indicating that there is only a difference of.001¿.Functional analysis was not performed due to the damage observed on the distal tip.The distal tip was analyzed using a vision system to magnify the damaged area.The distal core wire is fractured/separated in two parts.The distal core wire separated but remains attached to the distal coil wire.The proximal tip of the coil wire is attached to the core wire.The coil wire is still in one piece and no separated condition was observed presenting only the unraveling condition.The unraveling of the coil wire resulted in the exposure of the guidewire core wire.Sem analysis confirmed a fractured/separated condition to the core wire.It was noted to be separated into two pieces.The separated portion of the wire was returned for analysis and presented evidence of plastic deformation on the damaged areas of the unit.A product history record (phr) review of lot 3526312 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 ¿guidewire- resistance/friction - in patient¿ was not confirmed, the functional test could not be performed due to the damages on the distal tip.The failures ¿distal tip-wires ~ unraveled/stretched - in patient¿ and ¿guidewire- fractured/separated - in patient¿ were confirmed.The distal tip is unraveled, and the distal core wire is fractured/separated in two parts.The plastic deformations noted along the damaged area is evidence of material tensile overload.Therefore, it is assumed the material of the wire was induced to a tensile force that exceeded the wire material yield strength prior to the fracture/separation.The exact cause of these damages could not be conclusively determined during the analysis.Manipulating the wire through highly tortuous vasculature or the removing the wire from the dispenser by the distal tip are common causes of the reported events.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, ¿tip fractures have been reported in procedures involving total occlusions, highly tortuous vasculature, and small side branches.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.

• Brand Name: PGW .018 SV INTER 300CM ST
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15012728
• Report Number: 1016427-2022-05413
• Device Sequence Number: 2517836
• Product Code: DQX
• UDI-Device Identifier: 10705032056083
• UDI-Public: 10705032056083
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K930091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2022

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: 04/30/2023
• Device Model Number: 503658X
• Device Catalogue Number: 503658X
• Device Lot Number: 35263122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• 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: SWANZ GANZ CATHETER
• Patient Sex: Female
• Patient Weight: 76 KG