Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUETOME 49; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION TRUETOME 49; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00584150
Device Problem Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/16/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4) captures the reportable event of cutting wire orientation.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 a truetome 49 was used in the papilla during a cholangiopancreatography procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the truetome 49 was inclined to the right (1 hour direction) which was oriented in the wrong direction.Reportedly, they had to cannulate all the entire cutting wire as the orientation would not stay in place to the papilla.The procedure was completed with different device.There were no user injury nor patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that a truetome 49 was used in the papilla during a cholangiopancreatography procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the truetome 49 was inclined to the right (1 hour direction) which was oriented in the wrong direction.Reportedly, they had to cannulate all the entire cutting wire as the orientation would not stay in place to the papilla.The procedure was completed with different device.There were no user injury nor patient complications reported as a result of this event.
 
Manufacturer Narrative
(b)(4).Block h10: visual examination of the returned device revealed that the working length was twisted a the distal section.Functionally, the device was introduced inside the duodenoscope and the initial tip orientation was found out of specification due to the condition of the working length (twisted).In order to untwist the tip, the handle was rotated.After rotation the distal tip was inspected and the orientation was found within specifications.The complaint was consistent with the reported event of incorrect wire orientation.It is most likely that the failure found (working length twisted) is an issue that could have been generated by the user or due to the interacting of the device with the other devices used in the same procedure, and it is most likely that due to procedural factors encountered during the procedure the performance of the product was limited.Therefore the most probable cause of this complaint is adverse event related to procedure.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRUETOME 49
Type of Device
UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key7904768
MDR Text Key121564089
Report Number3005099803-2018-60565
Device Sequence Number1
Product Code KNS
UDI-Device Identifier08714729827610
UDI-Public08714729827610
Combination Product (y/n)N
PMA/PMN Number
K122203
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/26/2019
Device Model NumberM00584150
Device Catalogue Number47937
Device Lot Number0020816276
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2019
Date Manufacturer Received02/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-