MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HYDRATOME RX 49; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00583010
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date (b)(6) 2019 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The device has not been received for analysis.Upon receipt and 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 49 was used during a sphincterotomy procedure.According to the complainant, the cutting wire broke during sphincterotomy.Additionally, a photo of the device was provided which showed that the cutting wire was also kinked.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block b3 (date of event): the exact date of the event is unknown.The provided event date (b)(6) 2019 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6 (device codes): the problem code 1069 captures the reportable event of cutting wire broken.Block h10: visual examination of the returned device revealed that the cutting wire was broken and blackened.In addition, the working length was kinked.The complaint was consistent with the reported event of cutting wire broke.It is most likely that a peak of voltage could have caused the failures noted, also the working length was found kinked, it is a known issue caused during manipulation of the device or due to the interaction with the endoscope or with other devices.Therefore, the most probable cause of this complaint is adverse event related to procedure since it is the most likely that the adverse event occurred during the procedure and the device had no influence on event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release to distribution.
Event or Problem Description
It was reported to boston scientific corporation that a hydratome rx 49 was used during a sphincterotomy procedure.According to the complainant, the cutting wire broke during sphincterotomy.Additionally, a photo of the device was provided which showed that the cutting wire was also kinked.There were no reported patient complications as a result of this event.

• Brand Name: HYDRATOME RX 49
• 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: 8670110
• Report Number: 3005099803-2019-02818
• Device Sequence Number: 10835709
• Product Code: KNS
• UDI-Device Identifier: 08714729755166
• UDI-Public: 08714729755166
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2019

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: 11/03/2021
• Device Model Number: M00583010
• Device Catalogue Number: 8301
• Device Lot Number: 0022886956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 07/29/2019
• Patient Sequence Number: 1