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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 M0063903100
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2021
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used in the ureter during a transurethral lithotripsy procedure performed on an unknown date.During procedure, the distal tip of the sheath was damaged during laser radiation.No patient complications were reported due to this event.
 
Manufacturer Narrative
Date of event: approximated based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number; therefore, the expiration and device manufacture dates are unknown.Initial reporter name and address: (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Manufacturer Narrative
Date of event: approximated based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number; therefore, the expiration and device manufacture dates are unknown.Initial reporter name and address: (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used in the ureter during a transurethral lithotripsy procedure performed on an unknown date.During procedure, the distal tip of the sheath was damaged during laser radiation.No patient complications were reported due to this event.
 
Event Description
It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used in the ureter during a transurethral lithotripsy procedure performed on an unknown date.During procedure, the distal tip of the sheath was damaged during laser radiation.No patient complications were reported due to this event.
 
Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the expiration and device manufacture dates are unknown.Block e1: initial reporter city is (b)(6).Block h6: device code a0401 was used to capture the reportable event of distal section of sheath break.Block h10: the returned stone cone was analyzed, and a visual analysis found the coil was detached at the distal end.The detached coil was not returned.There were burn marks and signs of laser damage at/near the spot where the coil was detached.The reported event was confirmed.The instructions for use (ifu) warns the user "do not fire upon the device with a laser." however, the analyzed device provides clear evidence that it was fired upon by the laser.Based on all available information, the most probable root cause is unintended use error, indicating that interaction between the user and the device caused or contributed to the error.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
 
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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
el paso TX 79906
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key13196602
MDR Text Key286069948
Report Number3005099803-2022-00008
Device Sequence Number1
Product Code FGO
UDI-Device Identifier08714729430209
UDI-Public08714729430209
Combination Product (y/n)N
Reporter Country CodeJA
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,Followup
Report Date 04/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM0063903100
Device Catalogue Number390-310
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/25/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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