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

Model Number	M00584050
Medical Device Problem Codes	Failure to Align (2522); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a050701 captures the reportable event of wire was unable to release the bow.Block h11: investigation results the dreamtome rx 44 device was not returned; however, a media analysis was performed based on the photo provided by the complainant that shows the distal section of the device with the working length bent, additionally, by the picture, it is not conclusive if the wire is failing to unbow since the handle is not seen in picture to determine if it was in extended position (unbow).No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of wire failure to release bow (unbow) was unable to be confirmed.According to the media analysis performed, it is not conclusive if the wire is failing to unbow since the handle is not seen in picture to determine if it was in extended position (unbow).Additionally, media analysis found that the working length was bent, this problem could be caused by operational factors, the used technique for the device manipulation or by the interaction between the device and a hard surface.The investigation findings and all information available concludes the most probable root cause is an adverse event related to procedure.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a dreamtome rx 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) with stone clearance procedure to treat common bile duct stones performed on (b)(6) 2025.During the procedure, the tome was already bowed upon insertion into biopsy channel, even with the handle stretched out to maximum the tip would not straighten.The tome would not unbow and the tip was stuck in a curved shape with the cutting wire protruding.A photo of the complaint device was provided and showed the device in a bowing position.The procedure was completed with the original device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a050701 captures the reportable event of wire was unable to release the bow.Block h11: investigation results: the returned dreamtome rx 44 was analyzed, and a visual inspection found that the working length was twisted at distal section.A functional test was performed, and the device was actuated, the wire was able to bow but was unable to unbow completely.Media analysis was performed based on the photo provided by the complainant and shows the wire appears unable to unbow.Dimensional test was performed, the dimension was out of specification, it was determined that this problem caused due to an overly tensioned wire.The guidewire was found in good condition.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of wire failure to release bow (unbow) was confirmed.The results of the analysis performed on the returned device found that the wire was unable to unbow completely, also, the length dimension of the exposed cutting wire length was out of specification, and it was determined that the wire was overly tensioned, this problem is related with a manufacturing deficiency.The investigation findings and all information available concludes the most probable root cause is manufacturing deficiency.An investigation to address this problem is in progress.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a dreamtome rx 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) with stone clearance procedure to treat common bile duct stones performed on (b)(6) 2025.During the procedure, the tome was already bowed upon insertion into biopsy channel, even with the handle stretched out to maximum the tip would not straighten.The tome would not unbow and the tip was stuck in a curved shape with the cutting wire protruding.A photo of the complaint device was provided and showed the device in a bowing position.The procedure was completed with the original device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h2 (correction): block h6 (evaluation conclusion code) has been corrected.Block h6: imdrf device code a050701 captures the reportable event of wire was unable to release the bow.Block h11: investigation results the dreamtome rx 44 device was not returned; however, a media analysis was performed based on the photo provided by the complainant that shows the distal section of the device with the working length bent, additionally, by the picture, it is not conclusive if the wire is failing to unbow since the handle is not seen in picture to determine if it was in extended position (unbow).No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of wire failure to release bow (unbow) was unable to be confirmed.According to the media analysis performed, it is not conclusive if the wire is failing to unbow since the handle is not seen in picture to determine if it was in extended position (unbow).Additionally, media analysis found that the working length was bent, this problem could be caused by operational factors, the used technique for the device manipulation or by the interaction between the device and a hard surface.The investigation findings and all information available concludes the most probable root cause is an adverse event related to procedure.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a dreamtome rx 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) with stone clearance procedure to treat common bile duct stones performed on (b)(6) 2025.During the procedure, the tome was already bowed upon insertion into biopsy channel, even with the handle stretched out to maximum the tip would not straighten.The tome would not unbow and the tip was stuck in a curved shape with the cutting wire protruding.A photo of the complaint device was provided and showed the device in a bowing position.The procedure was completed with the original device.There were no patient complications reported as a result of this event.

• Brand Name: DREAMTOME RX 44
• Common Device Name: 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23350864
• Report Number: 3005099803-2025-05530
• Device Sequence Number: 8791314
• Product Code: KNS
• UDI-Device Identifier: 08714729778271
• UDI-Public: (01)08714729778271(17)280626(10)36855390
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K013153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00584050
• Device Catalogue Number: M00584050
• Device Lot Number: 0036855390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 10/20/2025; 12/23/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 10/21/2025; 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown