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

Model Number	M00583040
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a hydratome rx 44 was used in the common bile duct (cbd) and ampulla during a sphincterotomy and endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, while performing sphincterotomy, after using the cautery, the end of the cutting wire broke off.It was reported that no part of the cutting wire detached and fell into the patient.The device was removed from the scope as it was no longer needed to enlarge the opening of the ampulla.The sphincterotomy procedure was already 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 a0401 captures the reportable event of cutting wire broken.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.Block h11: investigation results the returned hydratome rx 44 was analyzed, and a visual and microscopic inspection found that the cutting wire was blackened, kinked and broken from the proximal pierce hole.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of wire break was confirmed.The results of the analysis performed on the returned device found that the cutting wire was kinked and broken from the proximal pierce hole.It is most likely that procedural or anatomical factors encountered during the use of the device could have affected the device performance and its integrity.Wire broken could have been generated if there was contact between the device and the scope during energization or if the device exceeds the maximum of voltage during procedure as per precautions of the device states, also energizing the device prior to performing sphincterotomy can compromise the cutting wire's integrity, also it can cause a premature cutting wire fatigue, leading to break it.Once the cutting wire breaks, any attempt to remove the device from the scope can bent the cutting wire as observed in the product analysis.Therefore, 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 in the common bile duct (cbd) and ampulla during a sphincterotomy and endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, while performing sphincterotomy, after using the cautery, the end of the cutting wire broke off.It was reported that no part of the cutting wire detached and fell into the patient.The device was removed from the scope as it was no longer needed to enlarge the opening of the ampulla.The sphincterotomy procedure was already completed with the original device.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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19368990
• Report Number: 3005099803-2024-02313
• Device Sequence Number: 7688621
• Product Code: KNS
• UDI-Device Identifier: 08714729755197
• UDI-Public: 08714729755197
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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 Expiration Date: 01/30/2025
• Device Model Number: M00583040
• Device Catalogue Number: 8304
• Device Lot Number: 0028782686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2022
• 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 Age: 75 YR
• Patient Sex: Female