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

Catalog Number	527300E
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, when the.014 300cm stabilizer was used with outback catheter, it wasn't going through as smoothly.The radiologist felt a lot of resistance.When taking the wire out, the distal tip came off got stuck inside the patient.A snare was then used to remove it successfully.The device will be returned for evaluation.
Additional Manufacturer Narrative
E1: (b)(6).Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, when the.014 300cm stabilizer was used with outback catheter, it wasn't going through as smoothly.The radiologist felt a lot of resistance.When taking the wire out, the distal tip came off got stuck inside the patient.A snare was then used to remove it successfully.The device will be returned for evaluation.Additional information was requested; however, the information was not obtained after multiple attempts.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b5, d4, g3, g6, h1, h2, and h11 a review of the manufacturing documentation associated with lot 35265810 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.
Event or Problem Description
As reported, when the.014 300cm stabilizer was used with outback catheter, it wasn't going through as smoothly.The radiologist felt a lot of resistance.When taking the wire out, the distal tip came off got stuck inside the patient.A snare was then used to remove it successfully.The device will be returned for evaluation.Additional information was requested; however, the information was not obtained after multiple attempts.
Additional Manufacturer Narrative
As reported, when the.014 300cm stabilizer was used with outback catheter, it wasn't going through as smoothly.The radiologist felt a lot of resistance.When taking the wire out, the distal tip came off and got stuck inside the patient.A snare was then used to remove it successfully.One non-sterile unit of an sgw.014 stabilizer 300cm extra support was received for analysis.Per visual analysis, the wire presented with a separation on the distal tip.Microscopic analysis on the vision system was performed near the separated area and presented evidence of plastic deformation on the core wire and coiled wire.Additionally, diameter reduction was noted on the coiled wire.Sem analysis was not required because the main material characteristics of the damage are observable under the zoom of the vision system.A product history record (phr) review of lot 35265810 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿distal tip - fractured-separated¿ was confirmed.The exact cause of the event cannot be determined with the available information however, the plastic deformation and diameter reduction found on the metallic material is commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the wire was induced to a tensile force that exceeded the metallic material yield strength prior to the damage.Handling factors such as manipulating the wire 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, ¿never push, auger, withdraw, or torque a guidewire that meets resistance.First, using fluoroscopy, determine the cause of resistance and take any necessary remedial action.Torquing or pushing a guidewire against resistance may cause guidewire damage, and/or guidewire tip separation, or direct damage to the vessel.Resistance may be felt and/or observed (via fluoroscopy) by noting any buckling of the guidewire tip.If guidewire tip prolapse is observed, do not allow the tip to remain in a prolapsed position; otherwise damage to the guidewire may occur.If any resistance is felt, e.G., due to vessel spasm, bent guidewire, or guidewire entrapment, while manipulating or removing the guidewire in the blood vessel: stop the procedure.Do not move or torque the guidewire.Using fluoroscopy, first determine the cause of the resistance, then take appropriate remedial action.If the guidewire is moved excessively, it may break or become damaged.This may cause blood vessel injury or result in fragments being left inside the vessel.¿ based on the available information, 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: STABILIZER
• 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: 19009318
• Report Number: 9681477-2024-00004
• Device Sequence Number: 9372270
• Product Code: DQX
• UDI-Device Identifier: 10705032056410
• UDI-Public: (01)10705032056410(17)240731(10)35265810
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K873403
• 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,Followup
• Report Date (Section B): 05/16/2024

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 Catalogue Number: 527300E
• Device Lot Number: 35265810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/01/2024; 05/08/2024
• Initial Report FDA Received Date: 03/31/2024
• Supplement Report FDA Received Date: 04/26/2024; 05/16/2024
• 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
• Outcome Attributed to Adverse Event: Other; Life Threatening
• Patient Sex: Unknown