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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ZERO TIP; DISLODGER, STONE, BASKET, URETERAL, METAL
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BOSTON SCIENTIFIC CORPORATION ZERO TIP; DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number M0063901050
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/30/2024
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a zero tip basket device was used during a ureteroscopy procedure performed on (b)(6) 2024.During the procedure, the physician used the basket around a stone, but the handle broke and the basket detached.It was reported that they were able to remove the remaining of the basket wires.The procedure was completed with another zero tip basket device.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of basket detached.
 
Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of basket detached.Block h10: investigation results the returned zero tip basket was analyzed, and a visual evaluation noted that the handle was in good condition and the sheath was kinked at the distal section.Microscopic examination was performed and the sheath was found to be torn at the proximal section; also, it was noticed that the basket was inside the sheath.Functional examination was performed, the handle was actuated and the basket was not able to open or close due to the condition of the device.Destructive test was performed, and the device was disassembled.; where it was confirmed that the basket got inside the sheath, but the basket was in good condition.With all the available information, boston scientific concludes that the reported event of handle break and basket detachment of device or device component were not confirmed, but the sheath was found to be torn and bent/kinked.Based on the investigation results this could be related to handling and manipulation of the device during procedure, it is probable that an excess of force applied to the device such as operational factors during their use could lead to tear and bend/kink the sheath causing that the basket got inside the sheath consequently affecting the functionality of the device.After visual, microscope, functional and destructive inspections in the complaint device, it was not possible to identify any evidence of the alleged issues on the device.Additionally, the evidence from the product record review did not identify a potential product quality issue or new patient harm.Taking all available information into consideration, the most probable cause of this complaint is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.
 
Event Description
It was reported to boston scientific corporation that a zero tip basket device was used during a ureteroscopy procedure performed on (b)(6) 2024.During the procedure, the physician used the basket around a stone, but the handle broke and the basket detached.It was reported that they were able to remove the remaining of the basket wires.The procedure was completed with another zero tip basket device.There were no patient complications reported as a result of this event.
 
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Brand Name
ZERO TIP
Type of Device
DISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
farshad fahimi
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key18741143
MDR Text Key335814085
Report Number2124215-2024-09703
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/20/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM0063901050
Device Catalogue Number390-105
Device Lot Number0033040534
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/30/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/12/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
Patient RaceWhite
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