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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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/28/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch 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 an endoscopic sphincterotomy (est) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the direction of the cutting wire was incorrect.The procedure was completed with another of the same 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
Block h6 (device codes): problem code a1502 captures the reportable event of incorrect cutting wire orientation.Block h10: the returned ultratome xl was analyzed, and a visual evaluation noted that the cutting wire and the working length were bent at the distal section.A functional evaluation noted that the initial orientation of the distal tip of the device when exiting the endoscope was correct; however, the cutting wire was not aligned since it was bent.No other problems with the device were noted.The reported complaint was confirmed.Upon analysis, it was found that the cutting wire and the working length were bent causing an incorrect orientation of the cutting wire.Based on the condition of the device, the problem found could have been caused by the manipulation of the device while advancing into the scope and anatomy or if the device was hit against a surface.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on the event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
 
Event Description
It was reported to boston scientific corporation that an ultratome xl was used in the common bile duct (cbd) during an endoscopic sphincterotomy (est) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the direction of the cutting wire was incorrect.The procedure was completed with another of the same 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 Key11196808
MDR Text Key227975065
Report Number3005099803-2020-06568
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 03/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/24/2022
Device Model NumberM00535920
Device Catalogue Number3592
Device Lot Number0025401482
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2021
Date Manufacturer Received02/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age59 YR
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