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

Model Number	M00583060
Medical Device Problem Codes	Leak/Splash (1354); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 was used in the biliary system during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.After introducing the hydratome rx 44 and the guidewire was stripped, it was noticed that there was severe air leak as the physician was not able to insufflate air into the bowel in order to visualize the papilla.Glucagon was used to decrease the movement of the small bowel with no success.The scope was checked for leaks and all buttons were exchanged including the biopsy valve before it was decided to cancel the procedure and reschedule for the following day.On (b)(6) 2021, a new scope was used and tested for air leaks.As soon as the second hydratome rx 44 was introduced and the guidewire was stripped, the same problem occurred.They again exchanged all buttons including the biopsy valve.The physician placed the guidewire back into the hydratome rx 44 and completed the procedure with a long wire system.In the physician's assessment the air leak was due to the hydratome rx 44 device.There were no patient complications reported as a result of this event.

• 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: 11888548
• Report Number: 3005099803-2021-02462
• Device Sequence Number: 19682980
• Product Code: KNS
• UDI-Device Identifier: 08714729755210
• UDI-Public: 08714729755210
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2021

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: 03/21/2024
• Device Model Number: M00583060
• Device Catalogue Number: 8306
• Device Lot Number: 0027014631
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1