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

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It was reported that when the stone basket was withdrawn from the renal pelvis into the ureter, the basket was torn off and remained in the ureter.According to the health care worker the basket could only be removed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.

• Brand Name: BARD DIMENSION STONE BASKET
• Type of Device: KIDNEY 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 Key: 14976922
• MDR Text Key: 295617941
• Report Number: 1835241-2022-00001
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Model Number: 042313
• Device Catalogue Number: 02106-13
• Device Lot Number: BMCSMM15
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 82 KG