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

Model Number	M00583050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a hydratome rx 44 device was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure.The procedure date is unknown.According to the complainant, during the procedure, it was noticed that there was "bubbling" during the cutting process.It was confirmed that there was no reported malfunction of the hydratome rx 44 device.The procedure was completed with this device.Post-ercp procedure, the patient had developed pancreatitis.The exact event date is unknown.The patient's hospitalization was prolonged with antibiotic therapy and continuous monitoring.In the physician's assessment, the cause of pancreatitis was due to "excessive inappropriate coagulation" caused by the "vector of coagulation power" being too high.Reportedly, the settings of the erbe vio3 electrosurgical unit (a non -bsc device) were lowered seemingly resolving the reported "excessive inappropriate coagulation." reportedly, the patient has been given more intensive medical care.

• 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: 11069209
• Report Number: 3005099803-2020-06361
• Device Sequence Number: 19499896
• Product Code: KNS
• UDI-Device Identifier: 08714729755203
• UDI-Public: 08714729755203
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K013153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M00583050
• Device Catalogue Number: 8305
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention