• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OMNITECH SYSTEMS, INC. BARD DIMENSION STONE BASKET KIDNEY STONE RETRIEVAL BASKET

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OMNITECH SYSTEMS, INC. BARD DIMENSION STONE BASKET KIDNEY STONE RETRIEVAL BASKET Back to Search Results
Model Number 042313
Device Problems Break (1069); Stretched (1601)
Patient Problems Laceration(s) (1946); Foreign Body In Patient (2687)
Event Date 11/25/2021
Event Type  Injury  
Event Description
It was reported that when the stone basket was withdrawn from the renal pelvis into the ureter, the basket was torn off and remained in the ureter. According to the health care worker the basket could only be removed through open surgery. The initial procedure had been canceled. Per follow up information received on 29 nov 2021, according to the physician the ureter was torn off during the procedure. The patient was successfully operated on (b)(6) 2021. The remainder of the stone basket was recovered, and the ureter was replanted.
 
Manufacturer Narrative
Dhr review was reviewed and no abnormalities were found. Qtm 2006-004, rev. E provides instructions to final destruction test the various joint types of the product. Test 1 which tests the distal tip to wire joint (2 wires) had results of 8. 61 pounds to 10. 70 pounds. Test 2-a and test 2-b tests each individual wire to shaft tube crimp and had results of 2. 50 up to 3. 16 pounds. Visual inspection: basket was fully articulated and thumbslide was fully retracted. The pinion knob was positioned at 7 o'clock and should have been at 12 o'clock. Physical inspection: cut sheath and removed shaft tubes. It was noticed that the crimp joint that holds the basket wires was intact. Nitinol wire was noticed still attached to the shaft tubes with the crimp. The wires of the basket assembly exhibited elongation and stress. Certificate of compliance was reviewed for lot number 49964, nitinol wire break load was certified at 5. 48 pounds. Each shaft tube contains one crimped nitinol wire. Although an exact conclusion cannot be reached, the product appeared to be within specification. All critical joints were intact. We cannot rule out user error as the force required to break nitinol wire is likely higher than the force to detach the ureter. Additionally, we do not know if there was a stone in the basket at the time of the incident. It appears that excessive force was used during the procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBARD DIMENSION STONE BASKET
Type of DeviceKIDNEY STONE RETRIEVAL BASKET
Manufacturer (Section D)
OMNITECH SYSTEMS, INC.
450 s. campbell street
suite 2
valparaiso IN 46385
Manufacturer Contact
diane leviner
450 s. campbell st.
suite 2
valparaiso, IN 46385
2195315531
MDR Report Key14976922
MDR Text Key295617941
Report Number1835241-2022-00001
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number042313
Device Catalogue Number02106-13
Device Lot NumberBMCSMM15
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/11/2022 Patient Sequence Number: 1
-
-