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	12/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Description of event according to the initial reporter: the end tip of the wire guide fall off, then a new wire guide was replaced and completed the procedure successfully.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
Manufacturer ref# (b)(4).Occupation: unknown.Similar to device marketed under pma/510(k): k171513.Investigation is still in progress.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Occupation: unknown.Similar to device marketed under pma/510(k): k171513.Investigation is still in progress.
Event or Problem Description
Description of event according to the initial reporter: the end tip of the wire guide fall off, then a new wire guide was replaced and completed the procedure successfully.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
Manufacturer ref# (b)(4).Summary of investigational findings: the tip of the wire guide fell off and the procedure was completed with another device.An investigation of the returned straight wire guide revealed an elongation starting 70mm from the most distal tip.The inner mandril had fractured close to the tip welding and protruded the elongation.However, the most distal part of the mandril was still attached to the welding, thus suggesting that the welding had been according to specifications and fixed the components distally as intended.Based on these investigation findings the exact reason for the damaged wire guide cannot be determined.However, as the wire guide appeared clean and as the tip of the inner mandril was curved, it is suggested that the wire guide was somehow damaged during attempts to alter the wire guide tip prior to use, but this is only speculation based on the very limited information provided.There are adequate controls in place to ensure the device was manufactured to specifications.It was assessed that because any discovered non-conformances were properly dispositioned before qc release, there is evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that nonconforming 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 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 13410769
• Report Number: 3002808486-2022-00048
• Device Sequence Number: 5233396
• Product Code: DQX
• UDI-Device Identifier: 00827002314535
• UDI-Public: (01)00827002314535(17)260909(10)E4156069
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2022

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: 09/09/2026
• Device Model Number: G31453
• Device Catalogue Number: TSMG-35-260-LES
• Device Lot Number: E4156069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2021
• 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
• Patient Sex: Unknown