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

Model Number	M00583050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure 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
It was reported to boston scientific corporation that a hydratome rx 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2020.According to the complainant, during the procedure, the cutting wire broke which caused bleeding.The physician administered 3cc of epinephrine to control the bleeding with adequate results.Additionally, the physician requested a flat and upright x-ray to rule out perforation and reportedly the results were normal.No part of the device was detached inside the patient.The procedure was completed with this device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fully recovered.
Additional Manufacturer Narrative
Block h6 (device codes): the problem code 1069 captures the reportable event of cutting wire broken.Block h10: the returned hydratome was analyzed, and a visual evaluation noted that the cutting wire was detached, bent and blackened; also the cut of the cutting wire was not smooth that shows it was not a mechanical cut.No other issues with the device were noted.The reported event was confirmed.The failure found could had been generated if the device was not in contact with the tissue when it was energized or by a peak of voltage.Additionally, during procedure bleeding was noticed, this was listed as an adverse event in dfu information; that said, the most probable cause of this failure is known inherent risk of device since the reported adverse event known and documented in the labeling (including both short or long term known complications or adverse reactions).Based on all gathered information, the most probalbe cause of this complaint is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a hydratome rx 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the cutting wire broke which caused bleeding.The physician administered 3cc of epinephrine to control the bleeding with adequate results.Additionally, the physician requested a flat and upright x-ray to rule out perforation and reportedly the results were normal.No part of the device was detached inside the patient.The procedure was completed with this device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fully recovered.

• 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
• MDR Report Key: 10215623
• Report Number: 3005099803-2020-02521
• Device Sequence Number: 19434146
• Product Code: KNS
• UDI-Device Identifier: 08714729755203
• UDI-Public: 08714729755203
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K013153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2020

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: 03/11/2023
• Device Model Number: M00583050
• Device Catalogue Number: 8305
• Device Lot Number: 0025342507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR