MAUDE Adverse Event Report: CORDIS CORPORATION DGW .035 MC STR 150CM TEF; WIRE, GUIDE, CATHETER

Model Number	502581
Medical Device Problem Codes	Fracture (1260); Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2022
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, during the use of a.035 emerald movable-core ptfe-coated straight tip150cm diagnostic guidewire the tip partially broke when removed.The device was visually inspected and the tip was partially detached (didn't detach completely) and it was frayed.The wire did not become fixed or caught at any time it was only when removed did the physician realized there was a strange curve.The physician assures no extra force was applied during use.The wire was removed from the dispenser by the distal floppy end.The procedure was carried out with a different non-cordis guidewire.There was no reported patient injury.The product was stored, handled, and prepped according to the instructions for use (ifu).The wire was not kinked or damaged in any way prior to insertion into the patient.The wire was not re-shaped by the user nor used for treatment of another lesion prior to the event.There was no difficulty tracking the wire through the vessel or lesion.The wire was not torqued against resistance and the wire behave ¿normally.¿ the device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: d4, g3, g6, h1, h2, h3, h6, and h10 complaint conclusion: as reported, while using an.035 emerald movable-core ptfe-coated straight tip150cm diagnostic guidewire the tip partially broke when removed.The device was visually inspected, and the tip was partially detached (did not detach completely) and it was frayed.The wire did not become fixed or caught at any time.It was only removed because the physician realized there was a strange curve.The physician assures no extra force was applied during use.The wire was removed from the dispenser by the distal floppy end.The procedure was carried out with a different non-cordis guidewire.There was no reported patient injury.The product was stored, handled, and prepped according to the instructions for use (ifu).The wire was not kinked or damaged in any way prior to insertion into the patient.The wire was not re-shaped by the user nor used for treatment of another lesion prior to the event.There was no difficulty tracking the wire through the vessel or lesion.The wire was not torqued against resistance and the wire behaved ¿normally.¿ a non-sterile guidewire ¿dgw.035 mc str 150cm tef¿ was received for evaluation.The guidewire was returned inside the dispenser tube.The device was thoroughly inspected observing no damages or anomalies.A product history record (phr) review of lot 35265454 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaints reported by the customer as ¿distal tip-wires ~ frayed/split/torn - in patient¿ and ¿distal tip-wires ~ fractured - in patient¿ were not confirmed.The returned guidewire does not present with any damages or anomalies.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, ¿to lengthen the flexible segment of a movable core guidewire, gently withdraw the core.To shorten the flexible segment, push the core in carefully.Caution: when the guidewire is in a vessel, do not advance the movable core if the tip is in a curved shape.Never twist or force the core because excessive force may cause it to penetrate the coil and damage the vessel.¿ 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: DGW .035 MC STR 150CM TEF
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15983537
• Report Number: 1016427-2022-05433
• Device Sequence Number: 20320853
• Product Code: DQX
• UDI-Device Identifier: 10705032055550
• UDI-Public: (01)10705032055550(17)250731(10)35265454
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K864058
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2023

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: 07/31/2025
• Device Model Number: 502581
• Device Catalogue Number: 502581
• Device Lot Number: 35265454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• 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: NON-CORDIS GUIDEWIRE.
• Patient Age: 65 YR
• Patient Sex: Male