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

Model Number	M00545160
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an autotome rx 49 was used in the bile duct during an endoscopic bile duct stent placement procedure performed on (b)(6) 2021.During the procedure, when attempting to perform endoscopic sphincterotomy (est) it was noticed that the "blade direction" of the device was incorrect.Est was not performed, and a tube stent was placed to complete the procedure.There were no patient complications reported as a result of this event.

• 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: 11782980
• Report Number: 3005099803-2021-01889
• Device Sequence Number: 19747600
• Product Code: KNS
• UDI-Device Identifier: 08714729415152
• UDI-Public: 08714729415152
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/06/2021

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: 11/24/2023
• Device Model Number: M00545160
• Device Catalogue Number: 4516
• Device Lot Number: 0026415630
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1