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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 M00535900
Device Problems Failure to Fold (1255); Defective Device (2588); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2021
Event Type  malfunction  
Manufacturer Narrative
This event was reported by the distributor.The physician is: (b)(6).(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 during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, "the physician found that the cutting wire was diverticuled on the tip of the ultratome xl and couldn't kink it".The procedure was not completed due to this event.There were no reported patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Event Description
It was reported to boston scientific corporation that an ultratome xl was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, "the physician found that the cutting wire was diverticuled on the tip of the ultratome xl and couldn't kink it".The procedure was not completed due to this event.There were no reported patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Manufacturer Narrative
Section e: this event was reported by the distributor.The physician is: (b)(6).Block h6 (device codes): medical device problem code a27 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: the returned ultratome xl was analyzed, and a visual evaluation noted that the working length was twisted at the distal section.The distal pierced hole was also torn which displaced the cutting wire anchor from its original position (the wire anchor is still within the catheter).These conditions are consistent with the findings when the device was observed under magnification.Additionally, the cutting wire was blackened.A functional evaluation was performed by actuating the handle, and the device did not bow due to torn distal pierced hole (tome's extrusion).No other problems with the device were noted.The reported event was confirmed.Upon analysis, it was found that the cutting wire was blackened, the working length was twisted, and the distal pierced hole was torn.Based on the device condition, the wire blackened could have been generated while electrical current was applied to the tissue.Twisted working length is a problem that could have been due to multiple attempts to rotate the device or during introduction of the device into the scope or due to user technique to remove the mandrel from the distal section of the device.Moreover, working length torn at the pierce hole could have been caused by a resistance felt at the cutting wire due to twisted working length during the handle actuation causing the catheter to tear and displacing the cutting wire anchor from its position, which could result in problems when bowing the device.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.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
2546 calle primera
alajuela
CS  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key12532264
MDR Text Key273316286
Report Number3005099803-2021-04959
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729103257
UDI-Public08714729103257
Combination Product (y/n)N
Reporter Country CodeEG
PMA/PMN Number
K930022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/18/2022
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 Date04/20/2023
Device Model NumberM00535900
Device Catalogue Number3590
Device Lot Number0027173177
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2021
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/02/2021
Initial Date FDA Received09/27/2021
Supplement Dates Manufacturer Received12/24/2021
Supplement Dates FDA Received01/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age60 YR
Patient SexMale
Patient Weight80 KG
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