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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 Defective Device (2588); Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/26/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The returned zero tip basket was analyzed, and a visual inspection noted that the sheath was torn and buckled accordion. The basket was returned with wires broken. Additionally, the basket had a discoloration in one wire. No other problems were noted. The reported event was confirmed. Based on all available information, the sheath torn buckled accordion could be cause due to the handling / manipulation, interaction with other device, excess of force applied during it use, consequently affected the device performance. Therefore, the most probable root cause of these failures is adverse event related to procedure. Also, the basket shows evidence of burned material, this failure may occur due to the contact of the basket with an electrified instrument and/or laser which can cause an overheating of the wires causing it to break. The instructions for use (ifu) states: warnings "this device should not be directly fired upon by any lithotrite. To do so may damage the device and could result in patient injury". Therefore, the most probable root cause is failure to follow instructions. A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution. A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
 
Event Description
It was reported to boston scientific corporation that a zero tip basket was used during a procedure performed on (b)(6) 2021. During procedure, the material was defective during use. No patient complications have been reported as a result of this event. Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts. The investigation revealed that the basket wire was detached; therefore, this is now an mdr reportable event.
 
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Brand NameZERO TIP
Type of DeviceDISLODGER, 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
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key14135496
MDR Text Key289467470
Report Number3005099803-2022-02105
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM0063901050
Device Catalogue Number390-105
Device Lot Number0026507131
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2022
Date Manufacturer Received04/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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