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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 M00535110
Device Problems Break (1069); Failure to Conduct (1114)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/12/2019
Event Type  malfunction  
Manufacturer Narrative
(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 a common bile duct stone removal procedure performed on (b)(6) 2019.According to the complainant, during the procedure, upon incision at the papilla, the cutting wire broke.Additionally, it was reported that the cutting ability of the stonetome was not good initially, and load resistance was applied.Reportedly, no part of the device was detached inside the patient.The procedure was completed with a second stonetome, using the same generator and active cord.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
The problem code 1069 captures the reportable event of cutting wire broken.Visual examination of the returned device revealed that the cutting wire was broken, bent and blackened causing the device cutting wire unable to energized.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 or if the device was not in contact with the tissue when it was energized.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.
 
Event Description
It was reported to boston scientific corporation that a stonetome was used in the papilla during a common bile duct stone removal procedure performed on (b)(6) 2019.According to the complainant, during the procedure, upon incision at the papilla, the cutting wire broke.Additionally, it was reported that the cutting ability of the stonetome was not good initially, and load resistance was applied.Reportedly, no part of the device was detached inside the patient.The procedure was completed with a second stonetome, using the same generator and active cord.There were no patient complications reported as a result of this event.
 
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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 Key9296922
MDR Text Key189700361
Report Number3005099803-2019-05417
Device Sequence Number1
Product Code LQR
UDI-Device Identifier08714729146599
UDI-Public08714729146599
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 12/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/21/2021
Device Model NumberM00535110
Device Catalogue Number3511
Device Lot Number0023676645
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2019
Date Manufacturer Received11/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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