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

Model Number	M00584000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2018
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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a dreamtome rx 49 was used in the lower bile duct during a bile ducts catheterization procedure performed on (b)(6) 2018.According to the complainant, during the sphincterotomy procedure, the cutting wire broke.Reportedly, no part of the device detached inside the patient.The procedure was completed with a second dreamtome rx 49, using the same generator and active cord.There were no user injuries nor patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a dreamtome rx 49 was used in the lower bile duct during a bile ducts catheterization procedure performed on (b)(6) 2018.According to the complainant, during the sphincterotomy procedure, the cutting wire broke.Reportedly, no part of the device detached inside the patient.The procedure was completed with a second dreamtome rx 49, using the same generator and active cord.There were no user injuries nor patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).Visual examination of the returned device revealed that the cutting wire was broken 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.Therefore, the complaint investigation conclusion code selected for this event is cause traced to component failure since the event was due to expected or random component failure without any design or manufacturing issue.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.

• Brand Name: DREAMTOME 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: 7972339
• Report Number: 3005099803-2018-60879
• Device Sequence Number: 1572349
• Product Code: KNS
• UDI-Device Identifier: 08714729778226
• UDI-Public: 08714729778226
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/20/2018

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: 07/08/2021
• Device Model Number: M00584000
• Device Catalogue Number: 47401
• Device Lot Number: 0022349242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1