FDA.reportPublic FDA data

MAUDE MDR 9799391

MDR report key
9799391
Report number
3011642792-2020-00004
Event key
0
Event type
3
Date of event
2020-01-22
Date received
2020-03-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. DAVID LOCKRIDGE
Address
1600 MERIT PARKWAY SOUTH JORDAN, UT US
Phone
208-208-2084
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MERIT MINI ACCESS KITACCESS KITMERIT MEDICAL SYSTEMSGCB00884450088838MAK-NV-016/AI1570906R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-060

Event Narratives#

N

Patient 1

THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

D

Patient 1

THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS NEPHROSTOMY TUBE PLACEMENT PROCEDURE ON AN ELDERLY FEMALE PATIENT, A MICROPUNCTURE ACCESS GUIDEWIRE TIP DETACHED. THE PHYSICIAN WAS ATTEMPTING NON-VASCULAR ACCESS WITH ECO/FLUOROSCOPIC GUIDANCE AT THE LOWER CALYX OF THE KIDNEY. DURING WIRE MANIPULATIONS THROUGH AN ACCESS NEEDLE, 4CM OF THE DISTAL 0.018 GUIDEWIRE DETACHED. THE DETACHED FRAGMENT OF THE NON-VASCULAR ACCESS WIRE REMAINS WITHIN THE PATIENT'S KIDNEY. A POST-PROCEDURAL COMPUTED TOMOGRAPHY [CT] SCAN WAS PERFORMED. CONSIDERING THE HEALTH CONDITIONS OF THE PATIENT AND THE EXISTING COMORBIDITIES, THE MEDICAL STAFF DECIDED NOT TO ATTEMPT TO RETRIEVE THE FOREIGN BODY FRAGMENT FROM THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

N

Patient 1

THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. PHOTOGRAPHS OF THE USED DEVICE WERE REVIEWED. THE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO EXCEPTION DOCUMENTS WERE FOUND.