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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 Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/01/2019
Event Type  malfunction  
Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(date of event): the exact date of the event is unknown.The provided event date (b)(6) 2019 was chosen as a best estimate based on the date that the manufacturer became aware of the event.The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.(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 common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure.According to the complainant, during the procedure, the stonetome was inserted into the papilla.The physician tried to perform incision but the cut wire was oriented in the wrong direction and could not be directed to the 11 o'clock direction.The stonetome was manipulated by any means; however, it did not turn towards the 11 o'clock direction.Reportedly, there was no visible damage to the device prior to putting it through the scope or after the issue occurred.The procedure was completed with a second stonetome.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 common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure.According to the complainant, during the procedure, the stonetome was inserted into the papilla.The physician tried to perform incision but the cut wire was oriented in the wrong direction and could not be directed to the 11 o'clock direction.The stonetome was manipulated by any means; however, it did not turn towards the 11 o'clock direction.Reportedly, there was no visible damage to the device prior to putting it through the scope or after the issue occurred.The procedure was completed with a second stonetome.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.Date of event: the exact date of the event is unknown.The provided event date (b)(6) 2019 was chosen as a best estimate based on the date that the manufacturer became aware of the event.The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.Device codes: problem code 3009 captures the reportable event of cutting wire orientation.Visual analysis of the returned device revealed no visual defects.The returned product looks under good conditions without evidence of damages or anomalies.Functionally, when the device was introduced inside the scope, the unit bowed more than 90 degrees outside and inside of the scope and the unit released the bow without problems.Based on all compiled information on this investigation, the most probable cause is no problem detected since the complaint included a returned device review which showed no evidence of either the alleged issue or any defect which could have contributed to the event.A manufacturing batch record review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a dhr history review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the 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 Key8546577
MDR Text Key143040618
Report Number3005099803-2019-02187
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 06/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00535150
Device Catalogue Number3515
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2019
Initial Date Manufacturer Received 04/02/2019
Initial Date FDA Received04/24/2019
Supplement Dates Manufacturer Received05/15/2019
Supplement Dates FDA Received06/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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