MAUDE Adverse Event Report: WILLIAM COOK EUROPE LUNDERQUIST SUPPORT WIRE GUIDE

Model Number	G49227
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Procode: dqx wire, guide, catheter.
Event or Problem Description
Description of event according to initial reporter: the tip of the wire broke off in the catheter.They had to snare the tip to remove it.They were not able to successfully manipulate the catheter.The dialysis is ok and flowing where it should.Additional information received on 01mar2021: it was a dialysis catheter and they had to use forcep to remove the tip of wire from the catheter.Patient outcome: 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.

• Brand Name: LUNDERQUIST SUPPORT WIRE GUIDE
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 11508171
• Report Number: 3005580113-2021-00037
• Device Sequence Number: 3971508
• Product Code: DQX
• UDI-Device Identifier: 00827002492271
• UDI-Public: (01)00827002492271(17)251130(10)E4045443
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2021
• Report Date (Section F): 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: G49227
• Device Catalogue Number: TSMG-35-145-7-LES
• Device Lot Number: E4045443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention