MAUDE Adverse Event Report: CORDIS CORPORATION SV018; WIRE, GUIDE, CATHETER

Catalog Number	503558
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the proximal part of the.018 180cm sv wire was striped.It was noted to have come off as a spiral.The damage was noted to be during use (inside of the patient) and after withdrawal from the patient.The guidewire was easily removed from the patient.A new unknown stiffer wire was used to complete the case.There was no reported injury to the patient.The wire was ¿normal¿ when removed from the package and inserted into the patient.The device was stored, handled, and prepped per the instructions for use (ifu).The tip of the guidewire was not shaped at any point during this procedure.The lesion was in the proximal portion of the superficial femoral artery (sfa).The vessel had moderate tortuosity and the lesion was noted to have moderate calcification.The guidewire was not being used with another device when the damage occurred.The device will be returned for evaluation.Additional information was requested; however, the information was not obtained.
Additional Manufacturer Narrative
E1 ph #: (b)(6).As reported, the proximal part of the.018 180cm sv wire was striped.It was noted to have come off as a spiral.The damage was noted to be during use (inside of the patient) and after withdrawal from the patient.The guidewire was easily removed from the patient.A new unknown stiffer wire was used to complete the case.There was no reported injury to the patient.The wire was ¿normal¿ when removed from the package and inserted into the patient.The device was stored, handled, and prepped per the instructions for use (ifu).The tip of the guidewire was not shaped at any point during this procedure.The lesion was in the proximal portion of the superficial femoral artery (sfa).The vessel had moderate tortuosity and the lesion was noted to have moderate calcification.The guidewire was not being used with another device when the damage occurred.A non-sterile unit of guidewire ¿pgw.018 sv short 180cm st¿ was received for analysis.The unit was thoroughly inspected observing that the radiopaque distal coil wire was unraveled.No other damages or anomalies were observed during visual analysis.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 tip of the core wire is fractured/separated in two pieces, and both segments were returned for analysis.Sem analysis was performed and presented evidence of plastic deformation identified on the surfaces near the separated sections.The failures reported by the customer as ¿guidewire~unraveled/stretched¿ and ¿distal tip~fractured-separated¿ were confirmed.Plastic deformation is found when materials are exposed to excessive mechanical stress, this happens when the resistance properties are overload and result in a fatigue failure.Therefore, it is assumed the wire was induced to a tensile force that exceeded its material yield strength prior to the failing.The exact cause of these findings cannot be conclusively determined during the analysis however, handling factors and/or patient vessel characteristics may be contributing factors.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, ¿cordis guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the peripheral vasculature.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 pull the distal tip to remove guidewire from dispenser as it may damage the tip.Tip fractures have been reported in procedures involving total occlusions, highly tortuous vasculature, and small side branches.¿ 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: SV018
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; butlersland new ross co.; wexford ; EI ; 7863138372
• MDR Report Key: 19506881
• Report Number: 1016427-2024-00012
• Device Sequence Number: 20688817
• Product Code: DQX
• UDI-Device Identifier: 10705032056052
• UDI-Public: (01)10705032056052(17)240831(10)35265832
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

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
• Device Expiration Date: 08/31/2024
• Device Catalogue Number: 503558
• Device Lot Number: 35265832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2022
• 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: N/A.
• Patient Sex: Unknown