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

Model Number	M00545160
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/02/2020
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 mdr will be filed.
Event or Problem Description
Note: this report pertains to a jagtome rx 49 and autotome rx 49 devices used during the same procedure.It was reported to boston scientific corporation that a jagtome rx 49 and autotome rx 49 was used in the papilla during extraction of biliary stone procedure performed on (b)(6) 2020.According to the complainant, during the procedure, when the physician cut the papilla using the jagtome rx 49, the cutting wire was broke after two seconds of cutting.The physician used another sphincterotome an autotome rx 49 and the same problem occurred, the cutting wire broke.Reportedly, no part of the device was detached inside the patient.The procedure was completed with a third jagtome rx 49.There were no patient complications reported as a result of this event.
Event or Problem Description
Note: this report pertains to a jagtome rx 49 and autotome rx 49 devices used during the same procedure.It was reported to boston scientific corporation that a jagtome rx 49 and autotome rx 49 was used in the papilla during extraction of biliary stone procedure performed on (b)(6), 2020.According to the complainant, during the procedure, when the physician cut the papilla using the jagtome rx 49, the cutting wire was broke after two seconds of cutting.The physician used another sphincterotome an autotome rx 49 and the same problem occurred, the cutting wire broke.Reportedly, no part of the device was detached inside the patient.The procedure was completed with a third jagtome rx 49.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
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, bent and blackened.There was no other issue noted.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 or if the device was not in contact with the tissue when it was energized.Therefore, the most probable cause of this complaint is adverse event related to procedure since 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.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.

• Brand Name: AUTOTOME 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: 9642411
• Report Number: 3005099803-2020-00173
• Device Sequence Number: 13953566
• Product Code: KNS
• UDI-Device Identifier: 08714729415152
• UDI-Public: 08714729415152
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K013153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

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: 09/29/2022
• Device Model Number: M00545160
• Device Catalogue Number: 4516
• Device Lot Number: 0024514839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1