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

Model Number	G31453
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Description of event according to initial reporter: in a patient undergoing transcatheter aortic valve replacement, the wire guide has been placed in its target position but is unravelled during entry into the valve transmitter and is replaced with the same rpn of wire guide to complete the procedure.The tip of wire guide was not altered prior to the procedure.After the wire guide was introduced into the patient, the wire guide was unravelled in the cardiac position.The wire guide was withdrawn in time without complications, and the procedure was completed by replacing it with a wire guide of the same type.Patient outcome: a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.D3) denmark.G1) denmark.G4) similar to device marketed under pma/510(k): k220137.Investigation is still in progress.This report is required by the fda under 21cfr 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.
Additional Manufacturer Narrative
Manufacturer¿s ref# (b)(4).After investigation the event is no longer considered reportable to fda.Summary of investigational findings: during transcatheter aortic valve replacement, the wire guide was placed in its target position but unraveled during entry into the valve transmitter and is replaced with the same rpn of wire guide to complete the procedure.The complaint is logged with a tsmg-35-260-les wire guide.Three photos of a curved wire guide were provided and showed the inner mandril had fractured in the distal end, thus allowing the outer windings to unravel and elongate.An unused, straight wire guide was returned, and an investigation revealed no sign of any damage and consequently the returned wire guide do not match the reported unraveling of a straight wire guide, or the curved wire guide in the photos provided.Therefore, unless the tip of the curved wire guide on the photos was damaged during tip alteration prior to use, the exact reason for the wire guide to unravel cannot be determined, but the complaint will be re-opened in case the complaint device is returned.However, it is noted that the wire guide was reportedly used for transcatheter aortic valve replacement, but according to the instructions for use the lunderquist extra-stiff wire guides are intended for use in the major vessels, the aorta and vena cava, including their access vessels and adjacent vessels.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 final 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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov
• Manufacturer (Section G): WIILIAM COOK EUROPE; sandet 6; bajeverskov 4632 ; DK 4632
• Manufacturer Contact: louise baekmand ; sandet 6; bjaeverskov 4632 ; DK 4632 ; 56868382
• MDR Report Key: 21362543
• Report Number: 3002808486-2025-00024
• Device Sequence Number: 20976653
• Product Code: DQX
• UDI-Device Identifier: 00827002314535
• UDI-Public: (01)00827002314535(17)291014(10)E4613125
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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: G31453
• Device Catalogue Number: TSMG-35-260-LES
• Device Lot Number: E4613125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• 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 Age: 56 YR
• Patient Sex: Male
• Patient Weight: 60 KG