MAUDE Adverse Event Report: CORDIS CORPORATION SV .018; WIRE, GUIDE, CATHETER

Model Number	503558
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 35264652 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 coil part of a.018 short 180cm sv steerable guidewire released from the core part.The guidewire was replaced with another unknown device and the pediatric percutaneous transluminal angioplasty (pta) procedure continued.There was no reported patient injury.The device will be returned for evaluation.Addendum: as per the product evaluation, a fractured/separated area of the core wire of the unit presented evidence of plastic deformation on the damaged end area.
Event or Problem Description
As reported, the coil part of a.018 short 180cm sv steerable guidewire released from the core part.The guidewire was replaced with another unknown device and the pediatric percutaneous transluminal angioplasty (pta) procedure continued.There was no reported patient injury.The device will be returned for evaluation.Per the product evaluation, a fractured/separated area of the core wire of the unit presented evidence of plastic deformation on the damaged end area.
Additional Manufacturer Narrative
As reported, the coil part of a.018 short 180cm sv steerable guidewire released from the core part.The guidewire was replaced with another unknown device and the pediatric percutaneous transluminal angioplasty (pta) procedure continued.There was no reported patient injury.A non-sterile guidewire (pgw.018 sv short 180cm st) was received for analysis.The guidewire presented with a fractured/separated condition to the distal coil wire.The separated segments were not returned for analysis.Additionally, the distal tip of the coil wire was noted to be unraveled/stretched resulting in the exposure of the core wire.Sem analysis was performed and presented evidence of plastic deformation on the ends of the damaged areas.A product history record (phr) review of lot 35264652 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The failures ¿distal tip-fractured/separated¿ and ¿distal tip-unraveled/stretched¿ were confirmed.A separation was observed on the distal end of the core wire and an unraveled condition was observed on the distal tip of the coil wire.The unraveling of the coil wire resulted in the exposure of the guidewire core wire.The plastic deformations are commonly associated with fractures/separations caused by material tensile overload.Therefore, it is assumed that the material of the wire was induced to a tensile force that exceeded the wire material yield strength prior to the separation.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: SV .018
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; butlersland new ross co.; wexford ; 7863138372
• MDR Report Key: 17239493
• Report Number: 9681477-2023-00116
• Device Sequence Number: 6708237
• Product Code: DQX
• UDI-Device Identifier: 10705032056052
• UDI-Public: (01)10705032056052(17)240131(10)35264652
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K930091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023

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: 01/31/2024
• Device Model Number: 503558
• Device Catalogue Number: 503558
• Device Lot Number: 35264652
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/31/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2022
• 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 UNKNOWN DEVICE
• Patient Sex: Unknown