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

Model Number	G49224
Medical Device Problem Codes	Fracture (1260); Device Handling Problem (3265)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Pma/510(k): k171513.Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: the wiring that is around the guide wire was loose and stuck inside the patient.The doctor had to cut it in pieces to get it out.Patient outcome: patient is ok now.
Event or Problem Description
Additional information received 21jan2021: physician took the wire out by an incision in the skin as it curled up on the way into the catheter.It went well and patient had no complications.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).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.
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Summary of investigational findings: it was reported that the wiring around the wire guide was loose and curled up on its way into the catheter.The wire stuck inside patient and catheter.A small incision in the patient was made for removal, but no other complications were reported and no additional procedure was required.No product was returned for analysis, but two photos of the wire guide inside the holder and placed in a plastic pouch were provided.According to the photos approx.15cm of the distal wire tip exited from the holder and the inner wire had fractured, thus causing a severe elongation of the coiled tip.Biological matter was attached to the most distal tip.Based on these photos the wire guide likely stuck inside the unknown catheter due to incompatibility or the wire tip was slightly damaged during altering prior to use and curled up/stuck ¿on the way into the catheter¿.The instructions for use caution that the end hole size and length of the catheter must be taken into consideration to ensure proper fit between the wire guide and catheter and also, that altering the tip configuration of the wire guide may result in damage.However, based on the photos and the information provided the exact reason for the damaged wire guide will be pure speculation, since no information concerning the catheter was provided and since the wire guide was not returned to assist the investigation.There are adequate controls in place to ensure the device was manufactured to specifications.It was assessed that because no non-conformances were detected, 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 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.
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 SUPPORT WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 10902524
• Report Number: 3002808486-2020-01104
• Device Sequence Number: 2478487
• Product Code: DQX
• UDI-Device Identifier: 00827002492240
• UDI-Public: (01)00827002492240(17)250812(10)E4006202
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2021

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: 08/12/2025
• Device Model Number: G49224
• Device Catalogue Number: TSMG-35-90-4-LES
• Device Lot Number: E4006202
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 01/21/2021; 04/26/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 02/04/2021; 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1