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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)

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BOSTON SCIENTIFIC CORPORATION DREAMTOME RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00584040
Device Problem Break (1069)
Patient Problem Burn(s) (1757)
Event Date 10/14/2020
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 medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a dreamtome rx 44 was used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020. According to the complainant, during procedure, the cutting wire broke in half while inside the patient. Reportedly, no part of the device detached and fell into the patient. The procedure was completed with another dreamtome device. Reportedly, the patient sustained some tissue burning distal from the ampulla in the small bowel; however, there was no treatment required for the burn. There were no additional patient complications reported as a result of this event.
 
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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 Key10794431
MDR Text Key215509511
Report Number3005099803-2020-05152
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K013153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM00584040
Device Catalogue Number8404
Device Lot Number0025799142
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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