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

Model Number	M00583050
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Impact code: (b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
Note: this report pertains to one of two hydratome rx 44 used in the same procedure.It was reported to boston scientific corporation that a hydratome rx 44 was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the endoscope was inserted and positioned into the patient.A hydratome rx 44 was then inserted to cannulate; however, the preloaded hydra jagwire guidewire would not advance through the tome without also causing the tome to advance.A second hydratome rx 44 was used and the same problem occurred.The procedure was not completed due to this event.It was reported that they would bring the patient back to attempt the procedure again and try a jagtome revolution device instead.There was no information as to when this would be performed.There were no patient complications reported as a result of this event.
Event or Problem Description
Note: this report pertains to one of two hydratome rx 44 used in the same procedure.It was reported to boston scientific corporation that a hydratome rx 44 was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2022.During the procedure, the endoscope was inserted and positioned into the patient.A hydratome rx 44 was then inserted to cannulate; however, the preloaded hydra jagwire guidewire would not advance through the tome without also causing the tome to advance.A second hydratome rx 44 was used and the same problem occurred.The procedure was not completed due to this event.It was reported that they would bring the patient back to attempt the procedure again and try a jagtome revolution device instead.There was no information as to when this would be performed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: impact code f1001 is being used to capture the reportable problem of aborted/cancelled procedure.Block h10: the returned hydratome rx 44 was analyzed, and a visual evaluation noted that the distal tip was kinked.The device was observed under magnification and the distal tip was slightly kinked, and had white marks of bending forces.A functional evaluation was performed since the preloaded hydra jagwire guidewire was also returned, and there was a problem with the wire insertion test due to the kink at the distal tip of the working length of the tome.No other problems with the device were noted.The reported event was confirmed.Upon analysis, it was found that the hydra jagwire guidewire could advance through the guidewire introducer and to the catheter of the tome; however, there was difficulty advancing the guidewire at the distal section due the kink.Based on the condition of the device, the problem found could have been generated due to operational factors, such as manipulating the device through difficult anatomy or the used technique for the device manipulation.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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: 13713045
• Report Number: 3005099803-2022-01212
• Device Sequence Number: 15072146
• Product Code: KNS
• UDI-Device Identifier: 08714729755203
• UDI-Public: 08714729755203
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 04/20/2022

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: 10/24/2024
• Device Model Number: M00583050
• Device Catalogue Number: 8305
• Device Lot Number: 0028265193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2021
• 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