• 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 DREAMTOME RX 44 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 DREAMTOME RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00584040
Device Problems Break (1069); Failure to Fold (1255); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The returned dreamtome rx 44 was analyzed, and a visual evaluation noted that the cutting wire was broken from the proximal pierce hole and also it was kinked, consistent to the findings when the device was observed under magnification. The cutting wire was also blackened. A functional inspection was not performed due to broken cutting wire. No other problems with the device were noted. The product analysis revealed that the cutting wire was broken, blackened, and kinked. The cutting wire being blackened indicates that the device was energized. These conditions could have been generated if there was contact between the device and the scope during energization or if the device exceeded the maximum of voltage during procedure as per precautions of the device states. Also, energizing the device prior to performing sphincterotomy can compromise the cutting wire's integrity, which can cause a premature cutting wire fatigue, leading to break it. Additionally kinking/bending the cutting wire can lead to break it. It is most likely that procedural or anatomical factors encountered during the use of the device could have affected the device performance and its integrity. 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 instructions for use (ifu) / product label.
 
Event Description
It was reported to boston scientific corporation that a dreamtome rx 44 was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021. During the procedure, the physician tried to extend the sphincterotomy; however, the device would not bow at all. The procedure was completed another of the same device. There were no patient complications reported as a result of this event. This event has been deemed a reportable event based on the investigation results: the cutting wire was broken.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDREAMTOME RX 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 Key13890859
MDR Text Key287851392
Report Number3005099803-2022-01525
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM00584040
Device Catalogue Number8404
Device Lot Number0027681372
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/16/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-