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

Model Number	M00583060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 report will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a hydratome rx 44 was used in the common bile duct during an endoscopic retrograde cholangiopancreatography procedure performed on (b)(6) 2018.According to the complainant, during the procedure, it was noticed that the cutwire on the tome broke when they were bowing to cut and do a sphincterotomy.There was no part of the device detached inside the patient.There were no injury nor patient complications reported as a result of this event.
Additional Manufacturer Narrative
Problem code 1069 captures the reportable event of wire broke.Visual examination of the returned device revealed that the wire anchor was dislodged; however, the cutting wire was not found to be broken.The dislodged wire anchor could be perceived by the user as a broken cutting wire, consequently confirming the reported complaint.Additionally, the distal tip was found to be damaged and the working length was found to be damaged (split/torn), therefore displacing the cutting wire and causing the wire anchor to be dislodged from the extrusion.It is most likely that during the procedure the device could have been damaged due to excessive manipulation of the product by the user or the interaction with other devices.Therefore, the most probable cause of this complaint is adverse event related to procedure since it is most likely that due to procedural factors encountered during the procedure, the performance of the product was limited.A review of the device history record (dhr) was performed and no anomalies were observed.The review confirmed that the accepted device met all manufacturing specifications.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
Event or Problem Description
It was reported to boston scientific corporation that a hydratome rx 44 was used in the common bile duct during an endoscopic retrograde cholangiopancreatography procedure performed on (b)(6) 2018.According to the complainant, during the procedure, it was noticed that the cutwire on the tome broke when they were bowing to cut and do a sphincterotomy.There was no part of the device detached inside the patient.There were no injury nor 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 1242
• MDR Report Key: 8188217
• Report Number: 3005099803-2018-61802
• Device Sequence Number: 16804472
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2019

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: 06/20/2021
• Device Model Number: M00583060
• Device Catalogue Number: 8306
• Device Lot Number: 0022285856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1