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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 Problems Difficult to Open or Close (2921); Appropriate Term/Code Not Available (3191)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/16/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr 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 rigid laser ureterolithotripsy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the device was inspected and found it was able to straighten.However, when the device was inserted into the patient, the coil failed to close in a spiral when activated to catch a stone.Several attempts were made but all were unsuccessful.The device was removed, and the procedure was not completed as a result of this event.There were no patient complications as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Manufacturer Narrative
Block h6: problem code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: visual analysis of the returned device found the white inner working length was torn and accordioned.This prevented the blue outer sheath from being able to retract and expose the coil entirely.The reported complaint of the device being unable to close into a coil was confirmed.Based on all available information, it is likely that excessive force during handling was applied while testing the device before the procedure, which caused the white inner working length to tear and accordion when inserted into the scope.This prevents the coil from being able to be used effectively.The instructions for use (ifu) warns against using excessive force when resistance is encountered while attempting to withdraw the coil.Therefore, the most probable root cause is unintended use error caused or contributed to event.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 stone cone nitinol retrieval coil was used in the ureter during a rigid laser ureterolithotripsy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the device was inspected and found it was able to straighten.However, when the device was inserted into the patient, the coil failed to close in a spiral when activated to catch a stone.Several attempts were made but all were unsuccessful.The device was removed, and the procedure was not completed as a result of this event.There were no patient complications as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
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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
MDR Report Key10502240
MDR Text Key220655080
Report Number3005099803-2020-03739
Device Sequence Number1
Product Code FGO
UDI-Device Identifier08714729430223
UDI-Public08714729430223
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/25/2022
Device Model NumberM0063903200
Device Catalogue Number390-320
Device Lot Number0005103660
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2021
Date Manufacturer Received02/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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