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

Model Number	M00583040
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: impact code f05 is being used to capture the reportable event of rescheduled procedure.
Event or Problem Description
Note: this report pertains to first of four hydratome rx 44 used during the same procedure.It was reported to boston scientific corporation that a hydratome rx 44 was used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2023.During the procedure, the hydratome rx 44 was inserted through the duodenoscope.After the device exited the duodenoscope, the physician had difficulty passing the guidewire through the tome due to friction.The same problem happened when the physician opened three more hydratome rx 44.It was reported that the physician attempted to reload the guidewire through the tome after flushing the tome with saline and wetting the guidewire; however, the same problem was still noticed.It was also noted that the patient had a very difficult anatomy to cannulate (periampullary diverticula and a duodenal mucosal fold) partially blocking the view of the ampulla.The physician was able to place a pancreatic duct stent; however, the procedure was rescheduled, and a second procedure was performed, treating the biliary leak and it was successfully completed.There were no patient complications reported as a result of this event.The patient was discharged from the hospital.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: impact code f05 is being used to capture the reportable event of rescheduled procedure.Block h10: the returned hydratome rx 44 was analyzed, and a visual evaluation noted that the working length was torn from the tip to the end of the rx channel, which is consistent with the findings when the device was observed under magnification.Additionally, it was difficult to advance the guidewire during the functional test.No other problems with the device were noted.The product analysis revealed that working length was torn from the end of the rx channel to the tip, which is typically caused when the user pulls/removes the guidewire through the c-channel, also the technique used during loading/removing the guidewire into the device could cause the catheter gets torn.After functional inspection, it was difficult to advance the jagwire through the autotome device.The condition of torn working length leads to the difficulty in advancing the guidewire.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.
Event or Problem Description
Note: this report pertains to first of four hydratome rx 44 used during the same procedure.It was reported to boston scientific corporation that a hydratome rx 44 was used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the hydratome rx 44 was inserted through the duodenoscope.After the device exited the duodenoscope, the physician had difficulty passing the guidewire through the tome due to friction.The same problem happened when the physician opened three more hydratome rx 44.It was reported that the physician attempted to reload the guidewire through the tome after flushing the tome with saline and wetting the guidewire; however, the same problem was still noticed.It was also noted that the patient had a very difficult anatomy to cannulate (periampullary diverticula and a duodenal mucosal fold) partially blocking the view of the ampulla.The physician was able to place a pancreatic duct stent; however, the procedure was rescheduled, and a second procedure was performed, treating the biliary leak and it was successfully completed.There were no patient complications reported as a result of this event.The patient was discharged from the hospital.

• 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: 17881392
• Report Number: 3005099803-2023-05265
• Device Sequence Number: 7418081
• Product Code: KNS
• UDI-Device Identifier: 08714729755197
• UDI-Public: 08714729755197
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/15/2023

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: M00583040
• Device Catalogue Number: 8304
• 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: 09/13/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 60 YR
• Patient Sex: Unknown