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
Event or Problem Description
Note: this report pertains to second 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.
Event or Problem Description
Note: this report pertains to second 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 bent at the distal section.Functionally, a spare guidewire was used to perform the test, the jagwire guidewire was difficult to advance through the autotome device.Per the dimensional inspection of the autotome, the internal diameter was measured into two different sections.The internal diameter on the large brown/green color bands section, it was found within specification; however, the internal diameter on the little brown/green color bands section, it was out of specification.No other problems with the device were noted.The reported event of kinked working length and guidewire difficult to advance were confirmed.Upon analysis, it was found that the working length was bent at the distal section, and it was difficult to advance the guidewire through the tome.The kinked working length could be caused by operational factors, such as manipulating the device through difficult anatomy or the used technique for the device manipulation.Functional evaluation revealed that the jagwire was difficult to advance through the autotome.Additionally, the internal diameter (id) of the catheter was out of specification.It was determined that the cause was related to manufacturing deficiency.Based on all gathered information, the root cause of this complaint is manufacturing deficiency.An investigation to address this problem has been opened.
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 bent at the distal section.Functionally, when a spare guidewire used to perform the test, it was difficult to advance the jagwire guidewire through the autotome device.No other problems with the device were noted.The reported event of kinked working length and guidewire difficult to advance were confirmed.Upon analysis, it was found that the working length was bent at the distal section, and it was difficult to advance the guidewire through the tome.The kinked working length could be caused by operational factors, such as manipulating the device through difficult anatomy or the used technique for the device manipulation.Although it was found that the jagwire guidewire was difficult to advance through the autotome device, there are some pending tests on the device to be performed, such as the measure of the internal diameter (id) of the catheter.The resolution of this problem is still being performed and is currently in progress.Since the product investigation does not lead to a clear conclusion about the cause of the reported adverse events, therefore, the most probable root cause of this complaint is conclusion not yet available as the conclusion is yet to be established and the investigation is still incomplete.
Event or Problem Description
Note: this report pertains to second 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: 17881612
• Report Number: 3005099803-2023-05266
• Device Sequence Number: 18085128
• 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,Followup
• Report Date (Section B): 01/03/2024

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 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: 11/15/2023; 12/13/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 12/11/2023; 01/03/2024
• 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