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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 Problems Break (1069); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/25/2019
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 biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the physician observed that it was difficult to advance the guidewire through the ultratome lumen.When the physician attempted to remove the guidewire, the cutting wire broke.Reportedly, there was no part of the device detached inside the patient.The procedure was completed with a second ultratome xl, using the same generator and active cord.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): the problem code 1069 captures the reportable event of cutting wire broken.Block h10: visual examination of the returned device revealed that the cutting wire was in good condition.Additionally, test guidewire was loaded into the guidewire port and it advance as intended.The complaint device was not consistent with the reported event that the cutting wire broke.Analysis of the returned device determined that the device did not present any visual issue and it worked as intended.Additionally, the review includes visual, dimensional and functional evaluations, which showed no evidence of either the alleged issue or any defect that could have contributed to the reported event.Therefore, the most probable cause is no problem detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.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 biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the physician observed that it was difficult to advance the guidewire through the ultratome lumen.When the physician attempted to remove the guidewire, the cutting wire broke.Reportedly, there was no part of the device detached inside the patient.The procedure was completed with a second ultratome xl, using the same generator and active cord.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 Key9355931
MDR Text Key179546794
Report Number3005099803-2019-05726
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 01/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/05/2021
Device Model NumberM00535920
Device Catalogue Number3592
Device Lot Number0023749957
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2019
Date Manufacturer Received12/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age52 YR
Patient Weight68
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