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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 No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/17/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a dreamtome rx 44 was used in the papilla during a sphincterotomy procedure performed on (b)(6) 2022.During the procedure, while performing sphincterotomy in the papilla, it was noticed that the wire at the distal tip of the catheter "got cut." the device was removed together with the endoscope assembly to prevent damage in the inner sheath of the endoscope.The device was changed and the procedure was performed accordingly.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
 
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 dreamtome rx 44 was used in the papilla during a sphincterotomy procedure performed on (b)(6) 2022.During the procedure, while performing sphincterotomy in the papilla, it was noticed that the wire at the distal tip of the catheter "got cut." the device was removed together with the endoscope assembly to prevent damage in the inner sheath of the endoscope.The device was changed and the procedure was performed accordingly.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
 
Manufacturer Narrative
Block h6: medical device problem code a0401 captures the reportable event of cutting wire broken.Block h10: the returned dreamtome rx 44 and its preloaded guidewire were analyzed, and a visual evaluation noted that the distal tip of the autotome and the distal tip (pebax) of the dreamwire guidewire were cut with a sharp object, consistent with the findings when the device was observed under magnification.The cut distal tip was not returned.No other problems with the device were noted.The reported event of cutting wire break could not be confirmed.Upon analysis, the returned device was incomplete.The cut distal tip portion of the tome and the guidewire was not returned for analysis to identify any problem with the device.Without proper evaluation to the distal tip of the device, it remains unknown what are the most probable causes that contributed to the event.Since the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event, the most probable root cause of this complaint is cause not established.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.
 
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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
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 Key14044041
MDR Text Key288802772
Report Number3005099803-2022-01753
Device Sequence Number1
Product Code KNS
UDI-Device Identifier08714729778264
UDI-Public08714729778264
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K013153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00584040
Device Catalogue Number8404
Device Lot Number0028624965
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/13/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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