MAUDE Adverse Event Report: LAKE REGION MEDICAL ZIPWIRE 150CM X 0.89MM; WIRE, GUIDE, CATHETER

Device Problems Component Missing (2306); Output Problem (3005)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/12/2022

Event Type  malfunction  

Event Description

The patient was brought to the operating room for a cysto retrograde pyelogram (rpg) lithotripsy with holmium laser and stent placement.Towards the end of the procedure the operating room tech noticed that the guide wire was not intact and that the "floppy" portion of the wire was missing.This was brought to the mds attention & the circulating nurse and the x-ray tech corroborate this interaction.The md then used the broken wire on hand.A post op film was taken, the patient went to pacu.The x-ray tech suggested that there might be a portion of wire still in the kidney/ureter.The dr confirmed the wire was still retained and the patient was taken back to the cysto room for the foreign body extraction.During the second procedure the wire was extracted (a 12" portion of the 60" zipwire) and a new stent was inserted.The patient was then taken back to pacu and subsequently discharged in good condition.

• Brand Name: ZIPWIRE 150CM X 0.89MM
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 14618874
• MDR Text Key: 293474318
• Report Number: 14618874
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/24/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Sex: Female