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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUETOME 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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BOSTON SCIENTIFIC CORPORATION TRUETOME 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00584180
Device Problems Break (1069); Material Integrity Problem (2978)
Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)
Event Date 09/21/2021
Event Type  Injury  
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 a truetome 44 was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021. During the procedure, the truetome 44 was prepared and set accordingly. When the device was energized to make a cut at the opening of the bile duct, the cutting wire broke. It was reported that no part of the cutting wire detached and fell into the patient; however, the cutting wire was stuck in the duct causing a perforation and bleeding. Hemostasis was performed with the aid of adrenaline and clip to stop the bleed. Additionally, it was reported that the tip of the device was "smashed". A second truetome 44 was then used to continue the procedure; however, the procedure was not completed as the access through the bile duct was lost. It was reported that there was no malfunction of the second truetome 44. The patient was admitted to the hospital beyond standard of care to allow the bile duct to recover and the patient is expected to fully recover. Note: photos of the complaint device outside the patient were provided by the customer and showed the cutting wire broken.
 
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Brand NameTRUETOME 44
Type of DeviceUNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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 Key12617976
MDR Text Key276563993
Report Number3005099803-2021-05222
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K122203
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/21/2022
Device Model NumberM00584180
Device Catalogue Number8418
Device Lot Number0025750229
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/21/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/12/2021 Patient Sequence Number: 1
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