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
Additional Manufacturer Narrative
As reported, the 0.018" 300cm straight (st) tip sv peripheral steerable guidewire (pgw) fell apart and became useless during the procedure.The lesion calcification was moderate, with no vessel tortuosity and thirty-per-cent stenosis.The product was being used in a male patient for a revascularization procedure using a femoral approach.The product was stored and handled according to the instructions for use (ifu).There was no damage noticed to the device prior to opening the package and no difficulty removing the device from the sterile packaging.The device was prepped per the ifu and there was no difficulty experienced in prepping the device.Neither the device nor the other devices used with the product kinked or bent at any time.The product was not resterilized and the wire was not re-shaped by the user.The event occurred when the guide was being removed.The wire tip was visible on fluoroscopy throughout the procedure.There was no difficulty tracking the wire through the vessel or lesion; there was no resistance/friction between the wire and other devices; the wire did not become fixed or caught at any time and it was removed intact (in one piece) from the patient.A non-sterile guidewire ¿pgw.018 sv inter 300cm st¿ was received for analysis.Visual inspection was performed, and the radiopaque distal coil wire was noted to be unraveled.A kinked/bent condition located approximately 7 cm from the proximal end was also observed.The distal tip was analyzed using a vision system to magnify the damaged area.The proximal tip of the coil wire is attached to the core wire.The unraveling of the coil wire resulted in the exposure of the guidewire core wire.The distal core wire is fractured/separated, and the missing segment was not returned for analysis.The coil wire is also fractures/separated, and the missing section was not included in the shipment for analysis.Sem analysis confirmed the fractured/separated condition with the wire noted to be separated into two or more pieces.Evidence of diameter reduction and plastic deformation was observed on the damaged areas of the unit.A product history record (phr) review of lot 35263141 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 ~ unraveled/stretched - in patient¿ was confirmed.The unraveling of the coil wire resulted in the exposure of the guidewire core wire.A kinked/bent and a fractured/separated condition on both the coil wire and the core wire was also observed.Diameter reduction and 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.
Event or Problem Description
As reported, the 0.018" 300cm straight (st) tip sv peripheral steerable guidewire (pgw) fell apart and became useless during the procedure.There was no reported patient injury.Two photographs were provided for review.Image 1 (srtab.Jpg) showed an opened pouch of an sv8 guide wire lot # 35263141 with what appears to be a guide wire, and the distal tip appears to be damaged.Image 2 (guia stab.Jpg) showed the distal tip of a guide wire in close up.The tip appears to be unraveled for approximately 1-1.5 cm, with the coil unwound from a central core.The lesion calcification was moderate, with no vessel tortuosity and thirty-per-cent stenosis.The product being used in a male patient for a revascularization procedure using a femoral approach.The product was stored and handled according to the instructions for use (ifu).There was no damage noticed to the device prior to opening the package and no difficulty removing the device from the sterile packaging.The device was prepped per the ifu and there were no difficulty experienced in prepping the device.Neither the device nor the other devices used with the product kinked or bent at any time.The product was not resterilized and the wire was not re-shaped by the user.The event occurred when the guide was being removed.The wire tip was visible on fluoroscopy throughout the procedure.There was no difficulty tracking the wire through the vessel or lesion; there was no resistance/friction between the wire and other devices; the wire did not become fixed or caught at any time and it was removed intact (in one piece) from the patient.Product evaluation revealed that the distal core wire is fractured/separated, and the missing segment was not returned for analysis.

• Brand Name: PGW .018 SV INTER 300CM ST
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; 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: 14938813
• Report Number: 1016427-2022-05412
• Device Sequence Number: 4557512
• Product Code: DQX
• UDI-Device Identifier: 10705032056083
• UDI-Public: 10705032056083
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K930091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/06/2022

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: 503658X
• Device Catalogue Number: 503658X
• Device Lot Number: 35263141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2022
• Initial Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2021
• 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 Sex: Male