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

Model Number	G45353
Medical Device Problem Codes	Flaked (1246); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Description of event according to initial reporter: while cleaning the lunderquist during evar procedure, there appears to be grey sludge left behind.Colleagues have confirmed that this was also noticed in previous procedures.On inspection of the wire guide it looks like there are patches where the coating is gone and the wire guide feels rough or rigid.The wire seems to have scrapings of the teflon coating coming off.The wire was used the entire procedure so no need for additional wires.
Additional Manufacturer Narrative
The manufacturer's reference number: (b)(4).G4: similar to device marketed under 510(k)/pma: k220137.Investigation is still in progress.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.
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).After investigation the event is no longer considered reportable as the device did not malfunction and is not likely to cause or contribute to death or serious injury if the malfunction were to recur.Summary of investigational findings: this complaint handles two similar cases where two different patients was exposed to a tscmg-35-260-7-les (same lot in both cases).While cleaning the lunderquist during evar procedure, there appears to be grey sludge left behind.Colleagues have confirmed that this was also noticed in previous procedures.On inspection of the wire guide it looks like there are patches where the coating is gone and the wire guide feels rough or rigid.They used the wire the entire procedure so no need for additional wires.No adverse effect was reported on patient.The complaint reported by the user was confirmed.The complaint is confirmed based on visual/and/or functional inspection.The wire guide was returned for evaluation.The device evaluation determined the following: the device evaluation confirmed several areas with peeled off coating.Consequently, the adhesion of the coating was tested and found insufficient.Therefore, appropriate actions have been taken and relevant personnel were notified.A review of the manufacturing records and/or specifications did not reveal any discrepancies/nonconformances that could have contributed to this complaint issue.The investigation concludes the complaint device was manufactured to specification.The review of the relevant manufacturing records confirms the failure has not previously occurred for this manufacturing lot.There is no evidence to suggest that the user did not follow the instructions for use and/or label.A definitive cause was identified, as the adhesion of the coating to the wire guide was found insufficient.An internal action is not deemed necessary as the complaint falls within the scope of an ongoing internal action regarding "coating peels off on les wire".After considering this event the risk associated with the use of this device is still deemed adequate.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.

• Brand Name: LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DK 4632
• Manufacturer Contact: louise baekmand ; sandet 6; bjaeverskov 4632 ; DK 4632 ; 56868382
• MDR Report Key: 23665669
• Report Number: 3002808486-2025-00250
• Device Sequence Number: 10431281
• Product Code: DQX
• UDI-Device Identifier: 00827002453531
• UDI-Public: (01)00827002453531(17)300915(10)E4753105
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: G45353
• Device Catalogue Number: TSCMG-35-260-7-LES
• Device Lot Number: E4753105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2025
• 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