MAUDE Adverse Event Report: CORDIS US. CORP SV018; WIRE, GUIDE, CATHETER

Model Number	503658
Medical Device Problem Codes	Fracture (1260); Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the distal tip of a.018 180cm sv straight tip 8cm distal taper guidewire was found frayed while inside of the patient.The sv - 8 guidewire was removed in one piece, and an unknown guidewire was used as a replacement to continue the procedure.There was no reported injury to the patient and the patient showed no signs of infectious disease.The device was stored, handled, and prepped per the instructions for use (ifu) and will be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 35265807 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the distal tip of a.018 180cm sv straight tip 8cm distal taper guidewire was found frayed while inside of the patient.The sv - 8 guidewire was removed in one piece, and an unknown guidewire was used as a replacement to continue the procedure.There was no reported injury to the patient and the patient showed no signs of infectious disease.The device was stored, handled, and prepped per the instructions for use (ifu) and will be returned for evaluation.Addendum: product evaluation revealed that the distal tip of the sv guidewire was fractured/separated.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, b5, d4, g3, g6, h1, h2, h3, h6, and h10.This device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available.However, it will be submitted within 30 days upon receipt.An updated review of the manufacturing documentation associated with lot 35265807 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.H3 other text : this device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available.However, it will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
This device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the distal tip of a.018 180cm sv straight tip 8cm distal taper guidewire was found frayed while inside of the patient.The sv - 8 guidewire was removed in one piece, and an unknown guidewire was used as a replacement to continue the procedure.There was no reported injury to the patient and the patient showed no signs of infectious disease.The device was stored, handled, and prepped per the instructions for use (ifu).A non-sterile unit of guidewire ¿pgw.018 sv inter 180cm st¿ was received for analysis.The guidewire was unpacked and laid it on a tray to be visually inspected.During visual inspection, the radiopaque distal coil wire was noted to be unraveled.A kinked condition located approximately 13 cm from the proximal end was also observed.The distal tip section 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 body of the core wire is intact with no exposed surfaces or signs of damage noted apart from the separation noted to the distal end of the core wire.The distal tip of the core wire and the distal tip of the coil wire are fractured/separated, and the missing segments were not returned for analysis.Sem analysis presented evidence of surface roughness elongations and striation on the surfaces near the separated sections.A product history record (phr) review of lot 35265807 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The failure ¿distal tip-frayed/split/torn¿ was not confirmed as this condition was not observed.However, the malfunction ¿distal tip-fractured/separated¿ was confirmed.A separation was observed on the distal tip of the core wire and the coil wire.The increased surface roughness, elongations and striation patterns identified on the surfaces near the separated sections are commonly associated with plastic deformation when materials are exposed to excessive mechanical stress.This happens when the resistance properties are overloaded, resulting in fatigue failure.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 US. CORP; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; butlersland new ross co.; wexford ; 7863138372
• MDR Report Key: 17277072
• Report Number: 9681477-2023-00118
• Device Sequence Number: 5309809
• Product Code: DQX
• UDI-Device Identifier: 10705032056076
• UDI-Public: (01)10705032056076(17)420731(10)35265807
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K930091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/31/2024

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: 07/31/2024
• Device Model Number: 503658
• Device Catalogue Number: 503658
• Device Lot Number: 35265807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 10/31/2023; 11/29/2023; 01/08/2024
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 11/22/2023; 12/22/2023; 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• 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: ANOTHER GUIDE.
• Patient Sex: Unknown