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

Model Number	M00584070
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a dreamtome rx 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the cutting wire of the dreamtome rx 44 broke during the sphincterotomy, causing superficial mucosal perforation.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: patient code e2114 captures the reportable event of perforation.Medical device problem code a0401 captures the reportable event of cutting wire broken.Block h2 (additional information): block b5, block d7a, and block h8 have been updated based on the additional information received on october 6, 2022.
Event or Problem Description
It was reported to boston scientific corporation that a dreamtome rx 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the cutting wire of the dreamtome rx 44 broke during the sphincterotomy, causing superficial mucosal perforation.Additional information received on october 6, 2022: the location of the superficial mucosal perforation was at the entrance of the papilla.There were no interventions performed to address the perforation as it was resolved on its own.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another of the same device.

• Brand Name: DREAMTOME 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: 15544106
• Report Number: 3005099803-2022-05808
• Device Sequence Number: 5636017
• Product Code: KNS
• UDI-Device Identifier: 08714729778295
• UDI-Public: 08714729778295
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2022

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: 08/08/2024
• Device Model Number: M00584070
• Device Catalogue Number: 8407
• Device Lot Number: 0028730746
• 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: 09/23/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown