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

Model Number M00583040

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

(date of event): 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 of receipt.(b)(4).The returned hydratome rx 44 was analyzed, and a visual evaluation noted that the cutting wire was broken.The device was observed under magnification and the cutting wire was blackened, the cut of the cutting wire was not smooth.A functional evaluation was performed by loading a test guidewire through the guidewire port using short and deliberate movements and it advanced through the tome.Bowing and continuity tests were not performed due to the condition of the device.Leakage test was performed by injecting water through the injection hub port and it flowed as intended.No other problems with the device were noted.The product analysis revealed that the cutting wire was broken and blackened.The cutting wire being blackened indicates that the device was energized.Based on the condition of the device, the problem found could have been generated if there was no constant contact with the tissue when electrocautery current was applied or if voltage exceeded the maximum voltage rating.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.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

Boston scientific received a hydratome rx 44 device with no associated information.Evaluation of the device revealed a broken cutting wire.Please see block for full investigation details.Based on follow-up with the sender, this hydratome rx 44 was used in a procedure.The procedure date is unknown.According to the complainant, there were three sphincterotomes wherein the cutting wire broke.The procedure was completed with a fourth 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 fine.Note: this report pertains to the first of three devices that were used in the same procedure.

Manufacturer Narrative

Additional information: block e1 (initial reporter first name and last name), block e3 (other initial reporter's occupation).Block b3 (date of event): 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 of receipt.Block h6 (device codes): problem code a0401captures the reportable event of cutting wire broken.Block h10: the returned hydratome rx 44 was analyzed, and a visual evaluation noted that the cutting wire was broken.The device was observed under magnification and the cutting wire was blackened, the cut of the cutting wire was not smooth.A functional evaluation was performed by loading a test guidewire through the guidewire port using short and deliberate movements and it advanced through the tome.Bowing and continuity tests were not performed due to the condition of the device.Leakage test was performed by injecting water through the injection hub port and it flowed as intended.No other problems with the device were noted.The product analysis revealed that the cutting wire was broken and blackened.The cutting wire being blackened indicates that the device was energized.Based on the condition of the device, the problem found could have been generated if there was no constant contact with the tissue when electrocautery current was applied or if voltage exceeded the maximum voltage rating.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.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

Boston scientific received a hydratome rx 44 device with no associated information.Evaluation of the device revealed a broken cutting wire.Please see block h10 for full investigation details.Based on follow-up with the sender, this hydratome rx 44 was used in a procedure.The procedure date is unknown.According to the complainant, there were three sphincterotomes wherein the cutting wire broke.The procedure was completed with a fourth 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 fine.Note: this report pertains to the first of three devices that were used in the same procedure.

• Brand Name: HYDRATOME RX 44
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11096448
• MDR Text Key: 225331704
• Report Number: 3005099803-2020-06418
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729755197
• UDI-Public: 08714729755197
• Combination Product (y/n): N
• PMA/PMN Number: K013153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2023
• Device Model Number: M00583040
• Device Catalogue Number: 8304
• Device Lot Number: 0025919575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Date Manufacturer Received: 01/25/2021
• Patient Sequence Number: 1