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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 Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/10/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4). According to the complainant, the suspect device has been disposed and is not available for return. If any further relevant information is received, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a zero tip basket was to be used in the ureter during a retrograde intrarenal surgery (rirs) procedure performed on (b)(6) 2022. During the preparation, the basket wire was broken and fully detached from the device. The procedure was completed with another zero tip basket. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was stable.
 
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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 Key13441980
MDR Text Key288372849
Report Number3005099803-2022-00414
Device Sequence Number1
Product Code FFL
UDI-Device Identifier08714729469643
UDI-Public08714729469643
Combination Product (y/n)N
Reporter Country CodeTW
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 02/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2022
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 Number0028019278
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/14/2021
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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