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

Model Number	M00583050
Medical Device Problem Codes	Failure to Fold (1255); Material Separation (1562); Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a hydratome rx 44 was used in the colon during a procedure performed on (b)(6) 2023.During the procedure, "the sphincterotome did not deploy (open)" and a strong resistance was encountered during the deployment.It was noticed that there was a plastic part left inside the patient's colon.The physician had to use another device to retrieve the plastic part.There were no reported patient complications as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Block h2 (additional information): block b5, block e1 (initial reporter last name, initial reporter phone), block e3, and block h6 (impact codes, device codes) have been updated based on the additional information received on january 27, 2023.Block h10: additional information received on january 27, 2023, confirmed that this is no longer considered a reportable event.The customer reported that they experienced difficulty advancing the guidewire and the distal tip of the guidewire detached inside the patient.The distal tip is a biocompatible hydrophilic tip that can be passed naturally by the patient.
Event or Problem Description
It was reported to boston scientific corporation that a hydratome rx 44 was used in the colon during a procedure performed on (b)(6) 2023.During the procedure, "the sphincterotome did not deploy (open)" and a strong resistance was encountered during the deployment.It was noticed that there was a plastic part left inside the patient's colon.The physician had to use another device to retrieve the plastic part.There were no reported patient complications as a result of this event.Additional information received on january 27, 2023: upon opening the device during preparation, there were no difficulties with the guidewire.However, during the procedure, the nurse had difficulty pushing the guidewire and felt as if the guidewire was blocked.The nurse continued to push a little bit harder, and the distal tip of the guidewire detached, blocked the distal part of the tome, and entered the patient's anatomy.The procedure was completed with another hydratome rx 44.Note: the distal tip is a biocompatible hydrophilic tip that can be passed naturally by the patient.

• 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: 16206957
• Report Number: 3005099803-2023-00137
• Device Sequence Number: 4341225
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2025
• Device Model Number: M00583050
• Device Catalogue Number: 8305
• Device Lot Number: 0029580771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown