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

Model Number	503558X
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product history review is expected but has not been completed.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 5 cm 300 cm straight tip sv steerable guidewire was found fractured after removal.Approximately 10-15 mm from the distal end the device separated.A non-cordis.018 glide wire was advanced, and a non-cordis stent was successfully deployed.The physician removed some of the guidewire via an unknown non-cordis micro snare.The remaining portion of the guidewire was trapped between a non-cordis stent and the artery wall as they intended on using that device for patient treatment.No future complications were noted.A 7f sheath was advanced into place.After crossing the carotid artery with the device, a non-cordis stent was advanced unsuccessfully.Then a.018 non-cordis glide wire was advanced, and a non-cordis was stent was successfully deployed.The wire was not removed from the dispenser by the distal floppy end.The device was not used for a chronic total occlusion (cto).The guidewire manipulation/torquing was performed under fluoroscopic guidance.There was no resistance encountered while advancing or withdrawing the guidewire.The guidewire did not become entrapped at any point in the procedure.The device was not being used on highly torturous vasculature.The device was not being used on small side branches.The guidewire was not exposed to a metal device.The patient's vessel characteristics were no calcification, tortuosity, stenosis, acute angle and or bifurcating.The torque control/tip response was not compromised while using the guidewire.There was no resistance met while advancing the device.Excessive torquing was not required.No resistance was met while advancing the device over the guidewire.There was no resistance met while withdrawing the device.The patient presented with a carotid rupture.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 35263851 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.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the distal tip of a.018 5 cm 300 cm straight tip sv steerable guidewire was found fractured after removal.Approximately 10-15 mm from the distal end the device separated.A non-cordis.018 glide wire was advanced, and a non-cordis stent was successfully deployed.The physician removed some of the guidewire via an unknown non-cordis micro snare.The remaining portion of the guidewire was trapped between a non-cordis stent and the artery wall as they intended on using that device for patient treatment.No future complications were noted.A 7f sheath was advanced into place.After crossing the carotid artery with the device, a non-cordis stent was advanced unsuccessfully.Then a.018 non-cordis glide wire was advanced, and a non-cordis stent was successfully deployed.The wire was not removed from the dispenser by the distal floppy end.The device was not used for a chronic total occlusion (cto).The guidewire manipulation/torquing was performed under fluoroscopic guidance.There was no resistance encountered while advancing or withdrawing the guidewire.The guidewire did not become entrapped at any point in the procedure.The device was not being used on highly torturous vasculature.The device was not being used on small side branches.The guidewire was not exposed to a metal device.The patient's vessel characteristics were no calcification, tortuosity, stenosis, acute angle and or bifurcating.The torque control/tip response was not compromised while using the guidewire.There was no resistance met while advancing the device.Excessive torquing was not required.No resistance was met while advancing the device over the guidewire.There was no resistance met while withdrawing the device.The patient presented with a carotid rupture.A non-sterile unit of guidewire ¿pgw.018 sv short 300cm st¿ was received for analysis.The unit was thoroughly inspected, and the radiopaque distal coil wire was noted to be unraveled.No other damages or anomalies were observed on the returned unit.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 and the distal tip of the coil wire are fractured/separated, and the missing segments were not returned for analysis.Sem results presented evidence of striation patterns and an increase of surface roughness identified on the separated sections of the core wire and coil wire.A product history record (phr) review of lot 35263851 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 ~ fractured - separated¿ was confirmed.A fractured/separated condition was noted on both the coil wire and the core wire.The observed striation patterns and increased surface roughness are commonly associated with elongations, which occur when the guidewire is exposed to excessive stress and results in material tensile overload.Therefore, it is assumed the wire was induced to a tensile force that exceeded its material yield strength prior to the fracture/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: SV018
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): CORDIS US CORP; 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 ; 7863138372
• MDR Report Key: 16885046
• Report Number: 9681477-2023-00105
• Device Sequence Number: 17665233
• Product Code: DQX
• UDI-Device Identifier: 10705032056069
• UDI-Public: (01)10705032056069(17)230930(10)35263851
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2023

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: 09/30/2023
• Device Model Number: 503558X
• Device Catalogue Number: 503558X
• Device Lot Number: 35263851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• 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: 04/14/2023
• Supplement Date Received by Manufacturer: 05/25/2023; 07/11/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 06/19/2023; 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2021
• 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: .018 TERUMO GLIDE WIRE.; 4/1/23 CAROTID STENT TREATMENT WITH VIABAHN STENT.; UNKNOWN 7F SHEATH.; UNKNOWN MICROSNARE.
• Patient Age: 61 YR
• Patient Sex: Female