MAUDE Adverse Event Report: WILLIAM COOK EUROPE LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G45208
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturers ref# (b)(4) blank fields on this form indicate the information is unknown or unavailable.Summary of investigational findings: during aortogram the wire was inserted into the non-cook pigtail catheter and would not come out.The tip frayed and came off the wellpoint, the whole system had to be removed.Another of the same devices were used to complete the procedure.The complaint device was not returned, the referenced photos were not obtained, and no additional information was provided.Therefore, based on the information provided only the exact reason for the wire guide to stick and fracture inside the non-cook catheter cannot be determined.There are adequate controls in place to ensure the device was manufactured to specifications.It is assessed that because any discovered non-conformances were properly dispositioned before release, there is evidence that the device was manufactured in compliance with procedures and according to specifications.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that non-conforming product exists in house or in field.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Description of event accordingh to initial reporter: the wire was inserted into the non-cook pigtail catheter and would not come out.The tip frayed and came off the wellpoint, the whole system had to be removed.Another of the same devices were used to complete the procedure.Patient outcome: no unintended section of this device remained inside the patient¿s body.The patient was not hospitalized and did not undergo prolonged hospitalization due to this occurrence.The patient did not experience a delay or require any additional procedure due to this occurrence.The complainant did not report any adverse effects on the patient due to this occurrence.

• Brand Name: LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 04632 ; DK 04632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 04632 ; DK 04632
• Manufacturer Contact: louise baekmand ; sandet 6; bjaeverskov 04632 ; DK 04632 ; 56868382
• MDR Report Key: 21584002
• Report Number: 3002808486-2025-00043
• Device Sequence Number: 18445908
• Product Code: DQX
• UDI-Device Identifier: 00827002452084
• UDI-Public: (01)00827002452084(17)290812(10)E4585286
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/12/2025

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 Model Number: G45208
• Device Catalogue Number: TSCMG-35-260-LESDC
• Device Lot Number: E4585286
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown