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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STONE CONE; DISLODGER, STONE, FLEXIBLE
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BOSTON SCIENTIFIC CORPORATION STONE CONE; DISLODGER, STONE, FLEXIBLE Back to Search Results
Model Number M0063903200
Device Problem Peeled/Delaminated (1454)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/14/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a stone cone was used in during a stone retrieval procedure performed on (b)(6) 2022.During withdrawal/closure, the coil broke in two parts.The procedure was completed with n-trap.There were no patient complications as a result of this event.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
STONE CONE
Type of Device
DISLODGER, STONE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
LAKE REGION MEDICAL
31c butterfield trail
el paso TX 79906
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key15998919
MDR Text Key308082011
Report Number3005099803-2022-07575
Device Sequence Number1
Product Code FGO
UDI-Device Identifier08714729430223
UDI-Public08714729430223
Combination Product (y/n)N
Reporter Country CodePE
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 Physician
Type of Report Initial
Report Date 12/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM0063903200
Device Catalogue Number390-320
Device Lot Number0006444309
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/03/2021
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
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