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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STONETOME; DISLODGER, STONE, BILIARY
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BOSTON SCIENTIFIC CORPORATION STONETOME; DISLODGER, STONE, BILIARY Back to Search Results
Model Number M00535150
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/08/2019
Event Type  malfunction  
Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a stonetome was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, after viewing the papilla with a scope, this device was advanced along the guidewire.When the handle was pulled to incise the papilla, it was noticed that the cutting wire broke.Reportedly, the broken cutting wire remained attached to the device and no part detached inside the patient.The procedure was completed with a second stonetome, using the same generator and active cord used to complete the procedure.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that a stonetome was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, after viewing the papilla with a scope, this device was advanced along the guidewire.When the handle was pulled to incise the papilla, it was noticed that the cutting wire broke.Reportedly, the broken cutting wire remained attached to the device and no part detached inside the patient.The procedure was completed with a second stonetome, using the same generator and active cord used to complete the procedure.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.The problem code 1069 captures the reportable event of cutting wire broken.Visual examination of the returned device found that the cutting wire was broken and blackened.There was no other issue noted.The complaint was consistent with the reported event of broken cutting wire.It is most likely that a peak of voltage could have caused the failures noted.Therefore, the most probable cause of this complaint is adverse event related to procedure since it is the most likely that the adverse event occurred during the procedure and the device had no influence on event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release to distribution.
 
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Brand Name
STONETOME
Type of Device
DISLODGER, STONE, BILIARY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8477742
MDR Text Key140744250
Report Number3005099803-2019-01624
Device Sequence Number1
Product Code LQR
UDI-Device Identifier08714729146667
UDI-Public08714729146667
Combination Product (y/n)N
PMA/PMN Number
K946358
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/24/2020
Device Model NumberM00535150
Device Catalogue Number3515
Device Lot Number0022704043
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/20/2019
Date Manufacturer Received04/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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