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

Model Number	503558
Medical Device Problem Codes	Fracture (1260); Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2022
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, during right heart catheterization the.018¿ sv5 peripheral steerable guidewire was inserted through a non-cordis catheter and noted to be frayed when exiting the tip of the catheter.The wire was immediately removed by the interventionalist.Another steerable guidewire was used, and the case was then completed.There was no reported patient injury.The device was being used for a right heart catheterization procedure.The device was not used for a chronic total occlusion.No lesion calcification or vessel tortuosity was noted.The product was handled according to the instructions for use (ifu).There were no visible signs of device/package damage prior to use; no anomalies noted when the device was taken out of the package and no excessive force applied to the device during withdrawal from package.The device prepped according to the ifu and there were no anomalies noted during or after the device was prepped.There was no unusual force used at any time during the procedure nor excess force used during insertion.The product was removed intact (in one piece) from the patient.The device was stored per labeling and opened in a sterile field.
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
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
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, during a right heart catheterization an.018¿ sv5 peripheral steerable guidewire was inserted through a non-cordis catheter and noted to be frayed when exiting the tip of the catheter.The wire was immediately removed by the interventionalist.Another steerable guidewire was used, and the case was then completed.There was no reported patient injury.The device was not used for a chronic total occlusion.No lesion calcification or vessel tortuosity was noted.The product was handled according to the instructions for use.There were no visible signs of device/package damage prior to use; no anomalies noted when the device was taken out of the package and no excessive force applied to the device during withdrawal from package.The device prepped according to instructions for use (ifu) and there were no anomalies noted during or after the device was prepped.There was no unusual force used at any time during the procedure nor excess force used during insertion.The product was removed intact (in one piece) from the patient.The device was stored per labeling and opened in a sterile field.A non-sterile unit of guidewire ¿pgw.018 sv short 180cm st¿ was received for analysis.The unit was thoroughly inspected observing the radiopaque distal coil wire was unraveled.Sem results of the separated area of the core wire presented evidence of diameter reduction and plastic deformation.Only the core wire was separated, the coiled wire did not present such damage.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 failure reported by the customer as ¿distal tip-wires ~ frayed/split/torn-in patient¿ was not confirmed, no frayed/split/torn condition was observed on the unit.The failure reported by the customer as ¿distal tip-wires ~ fractured¿ was confirmed, the distal tip of the coil wire is separated from the core wire.However, the proximal end of the coil wire remains attached to the core wire.The unraveling of the coil wire resulted in the exposure of the core wire.The plastic deformations, resulting in diameter reductions are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the material of the guidewire was induced to a tensile force that exceeded the wire material yield strength prior to the separation.The 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 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 33014-2802 ; 7863138372
• MDR Report Key: 13684186
• Report Number: 1016427-2022-05394
• Device Sequence Number: 11885701
• 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
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/27/2022

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 02/14/2022; 02/14/2022; 02/14/2022; 06/21/2022
• Initial Report FDA Received Date: 03/07/2022
• Supplement Report FDA Received Date: 03/31/2022; 04/26/2022; 05/20/2022; 06/27/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SV-5 WIRE, AND 6FR EDWARDS SWANN.
• Patient Sex: Female