DUALOK LOCALIZATION WIRE
Received Sep 21, 2020
Report 2020394-2020-05728 · MDR key 10559831
Device
Generic name
Localization Wire
Manufacturer
Bard Peripheral Vascular, Inc.Catalog number
UNK DUALOK
Lot number
UNKNOWN
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE.
Description of Event or Problem
IT WAS REPORTED THAT SIX MONTHS POST MARKER PLACEMENT, THE DEVICE ALLEGEDLY BROKEN. IT WAS FURTHER NOTED THAT THE PORTION OF THE WIRE WAS LEFT BEHIND WITHIN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.