MERIT MAK¿

Additional Manufacturer Narrative

THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD AND SEARCH OF THE COMPLAINT DATABASE COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED.

Description of Event or Problem

A CER LITERATURE SEARCH FOR THE MAK GUIDE WIRE PRODUCT FAMILY CONTAINED THE STUDY, "AN UNUSUAL CASE OF A 0.018-INCH GUIDEWIRE FRACTURE DURING PRIMARY PERCUTANEOUS NEPHROSTOMY" BY OH ET AL. (2024). A GUIDEWIRE FRACTURE OCCURRED DURING PERCUTANEOUS NEPHROSTOMY. THE DISTAL SEGMENT OF THE GUIDEWIRE REMAINED WITHIN THE KIDNEY AND COULD NOT BE RETRIEVED DESPITE MULTIPLE ATTEMPTS. SIX MONTHS LATER, THE PATIENT DEVELOPED INFECTION REQUIRING HOSPITALIZATION AND ANTIBIOTIC TREATMENT, WITH IMAGING CONFIRMING THE RETAINED FRAGMENT. NO ADDITIONAL DETAILS WERE PROVIDED.