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

Model Number	M00583050
Medical Device Problem Codes	Break (1069); Failure to Fold (1255); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a hydratome rx 44 was used during a procedure performed on an unknown date.It was reported that it was impossible to tension the device, the cutting wire broke from the beginning of use.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.Block h11: investigation results.The returned hydratome rx 44 was analyzed, and a visual and microscopic inspection found that the distal pierced hole was torn; therefore, this condition displaced the cutting wire anchor from its original position (the wire anchor is still within the catheter), due to this condition the device was not able to bow during a functional inspection.The cutting wire was not broken but was kinked.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of cutting wire break was not confirmed.The results of the analysis performed on the returned device found that the cutting wire was not broken but was kinked.Additionally, the distal pierced hole was torn (working length torn) and this condition limited the overall performance of the device making the device unable or difficult to bow.The working length torn at the pierce hole could have been caused by submitting the catheter to tension forces during the handle actuation, also bowing the device without being completely out of the scope can lead to tear it and displace the cutting wire anchor from its position.Also, the cutting wire was observed kinked, this problem could be caused by operational factors, such as manipulating the device through difficult anatomy, the used technique for the device manipulation or by the interaction between the device and the scope (hitting against 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 hydratome rx 44 was used during a procedure performed on an unknown date.It was reported that it was impossible to tension the device, the cutting wire broke from the beginning of use.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.

• Brand Name: HYDRATOME 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21649280
• Report Number: 3005099803-2025-01083
• Device Sequence Number: 13111943
• Product Code: KNS
• UDI-Device Identifier: 08714729755203
• UDI-Public: (01)08714729755203(17)271001(10)34971318
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: M00583050
• Device Catalogue Number: M00583050
• Device Lot Number: 0034971318
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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