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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRATOME XL; SNARE, FLEXIBLE

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BOSTON SCIENTIFIC CORPORATION ULTRATOME XL; SNARE, FLEXIBLE Back to Search Results
Model Number M00535920
Device Problem Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/08/2019
Event Type  malfunction  
Manufacturer Narrative
(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 mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that an ultratome xl was used in the common bile duct (cbd) during a stone removal procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the scope elevator was in neutral position when it was noticed that the cutting wire orientation was incorrect.Reportedly, there was no tortuous anatomy impacting scope positioning and no visible damage to the device prior to putting it through the scope or after the issue occurred.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Device codes: the problem code 3009 captures the reportable event incorrect cutting wire orientation.Visual examination of returned product revealed that the working length was twisted and the cutting wire was kinked at the distal section.The complaint was consistent with the reported event of incorrect orientation which could have been affected by twisted working length.Working length twisted and cutting wire kinked are known issues caused during manipulation of the device or due to the interaction with the endoscope or with other devices.Based on all compiled information on this investigation, the most probable cause of this complaint is adverse event related to procedure, the adverse event occurred during the procedure and the device had no influence on the 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.Correction to device manufacture date.
 
Event Description
It was reported to boston scientific corporation that an ultratome xl was used in the common bile duct (cbd) during a stone removal procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the scope elevator was in neutral position when it was noticed that the cutting wire orientation was incorrect.Reportedly, there was no tortuous anatomy impacting scope positioning and no visible damage to the device prior to putting it through the scope or after the issue occurred.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
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Brand Name
ULTRATOME XL
Type of Device
SNARE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8477975
MDR Text Key140771232
Report Number3005099803-2019-01625
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729103318
UDI-Public08714729103318
Combination Product (y/n)N
PMA/PMN Number
K930022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/29/2019
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 Expiration Date07/31/2020
Device Model NumberM00535920
Device Catalogue Number3592
Device Lot Number0022458308
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2019
Initial Date Manufacturer Received 03/08/2019
Initial Date FDA Received04/03/2019
Supplement Dates Manufacturer Received05/07/2019
Supplement Dates FDA Received05/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age41 YR
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