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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 M00584050
Device Problems Break (1069); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/21/2019
Event Type  malfunction  
Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was approximately (b)(6) years old.(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 a dreamtome rx 44 was used in the biliary during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, after cannulation of the common bile duct, the physician went to perform sphincterotomy.After completing approximately three quarters of the sphincterotomy, the cutting wire broke and became blackened.A photo of the complaint device was provided which confirmed the cutting wire was broken, bent, and blackened.Reportedly, no part of the device was detached inside the patient.The procedure was completed with a second dreamtome rx 44.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
Patient's exact age is unknown; however it was reported that the patient was approximately 80 years old.(device codes): the problem code 1069 captures the reportable event of cutting wire broken.The product analysis was performed based on a photo of the device that the complainant provided since the complaint device was not returned.The photo revealed that the cutting wire was broken, kinked and blackened; consequently, confirming the reported complaint.According to the photo provided by the customer the cutting wire of the device was broken, kinked and blackened.It is most likely that a peak of voltage could have caused the failures noted or if the device was not in contact with the tissue when it was energized.Therefore, the most probable cause of this complaint is adverse event related to procedure since it is the most likely that the adverse event occurred during the procedure and the device had no influence on event.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.
 
Event Description
It was reported to boston scientific corporation that a dreamtome rx 44 was used in the biliary during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, after cannulation of the common bile duct, the physician went to perform sphincterotomy.After completing approximately three quarters of the sphincterotomy, the cutting wire broke and became blackened.A photo of the complaint device was provided which confirmed the cutting wire was broken, bent, and blackened.Reportedly, no part of the device was detached inside the patient.The procedure was completed with a second dreamtome rx 44.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
DREAMTOME RX 44
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 Key9315073
MDR Text Key189705430
Report Number3005099803-2019-05552
Device Sequence Number1
Product Code KNS
UDI-Device Identifier08714729778271
UDI-Public08714729778271
Combination Product (y/n)N
PMA/PMN Number
K013153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/10/2022
Device Model NumberM00584050
Device Catalogue Number8405
Device Lot Number0024416744
Was Device Available for Evaluation? No
Date Manufacturer Received11/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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