MAUDE Adverse Event Report: LAKE REGION MEDICAL ZIPWIRE HYDOPHILIC GUIDEWIRE; WIRE, GUIDE, CATHETER

Catalog Number	M006630216B0
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A patient undergoing central venous line placement, very difficult procedure due to prior central venous line history, with short bowel syndrome.During the procedure, the left internal jugular vein was accessed percutaneously.Due to central venous stenosis, a zipwire hydrophilic guidewire (150cm straight tip 0.025in, lot 10995369) was used.While maneuvering the wire, the coating of the wire was sheared off remaining within the patient.The black outer coating peeled off and was now a foreign body within the patient.This was visualized on fluoroscopy and ultrasound to be within the left internal jugular vein itself.This was removed entirely through an already present incision which was enlarged slightly to accommodate retrieval of the foreign body.The fragment was removed entirely under direct visualization.Fluoroscopy confirmed complete removal.There was no blood loss or injury to the patient attributable to this event other than enlarging slightly an already present incision manufacturer response for guidewire, zipwire hydrophilic guidewire (per site reporter).Voice mail message left 5 days later for lake region medical with information regarding shearing of coating from guidewire.

• Brand Name: ZIPWIRE HYDOPHILIC GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine dr; chaska MN 55318
• MDR Report Key: 7850734
• Report Number: 7850734
• Device Sequence Number: 19252247
• Product Code: DQX
• UDI-Device Identifier: 08714729880783
• UDI-Public: (01)08714729880783
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2018
• Report Date (Section F): 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M006630216B0
• Device Lot Number: 10995369
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2018
• 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: Other
• Patient Weight: 17
• Date Report Sent to FDA: 08/08/2018