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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 07/14/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure 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 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 the same original 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
Correction - block g1 (mfr site facility name): corrected from boston scientific de costa rica s.R.L.To boston scientific corporation.Block h6 (device codes): problem code 3009 captures the reportable event of incorrect cutting wire orientation.Block h10: the returned ultratome xl was analyzed, and a visual evaluation noted that the working length was twisted and bent at 79 cm from distal tip; also, the exposed cutting wire was bent.Functional evaluation was performed.The device was introduced into the scope using short and deliberate movements, when the distal tip of the device exits the scope, the initial orientation of the device was incorrect due to the working length twisted.No other issues with the device were noted.The reported event was confirmed.Upon analysis the cutting wire was found bent and the working length was bent and twisted causing an incorrect orientation of the catheter and wire as the device exited the scope.The failure found could had been generated during manipulation of the device or due to the interaction with the endoscope or with other devices.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
 
Event Description
It was reported to boston scientific corporation that an ultratome xl was used in the common bile duct (cbd) during 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 the same original 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 Key10399749
MDR Text Key202768727
Report Number3005099803-2020-03269
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 09/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/22/2021
Device Model NumberM00535920
Device Catalogue Number3592
Device Lot Number0024820499
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2020
Date Manufacturer Received08/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age65 YR
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