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

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ZERO TIP DISLODGER, STONE, BASKET, URETERAL, METAL

  • 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
 

BOSTON SCIENTIFIC CORPORATION ZERO TIP DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number M0063901040
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/22/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). According to the complainant, the suspect device 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 used in the ureter during a ureteroscopy procedure performed on (b)(6) 2021. During the procedure, a laser was used on the left ureteral stone. The zero tip basket was then used to retrieved the stones. However, the basket wires broke into two separate pieces within the ureter. A different type of basket was used to snare the broken pieces. The procedure was delayed approximately 15 - 20 minutes due to this event. There were no patient complications as a result of this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key13525206
MDR Text Key288116183
Report Number3005099803-2022-00643
Device Sequence Number1
Product Code FFL
UDI-Device Identifier08714729469636
UDI-Public08714729469636
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM0063901040
Device Catalogue Number390-104
Device Lot Number0028136645
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/04/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/14/2022 Patient Sequence Number: 1
-
-