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

Model Number	M00584010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2018
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 dreamtome rx 49 was used in a procedure performed on (b)(6) 2018.According to the complainant, during the biliary sphincterotomy procedure for extraction of a calculi, the cutting wire broke in its proximal part.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available; a supplement report will be submitted.
Additional Manufacturer Narrative
Problem code 1069 captures the reportable event of wire broke.Visual examination of the returned device revealed that the cutting wire was broken and blackened.There was no other issue noted.It is most likely that a peak of voltage could have caused the failures noted.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 dreamtome rx 49 was used in a procedure performed on (b)(6) 2018.According to the complainant, during the biliary sphincterotomy procedure for extraction of a calculi, the cutting wire broke in its proximal part.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available; a supplement report will be submitted.

• 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 1242
• MDR Report Key: 8187513
• Report Number: 3005099803-2018-61832
• Device Sequence Number: 1359302
• Product Code: KNS
• UDI-Device Identifier: 08714729778233
• UDI-Public: 08714729778233
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2019

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: 08/20/2021
• Device Model Number: M00584010
• Device Catalogue Number: 8401
• Device Lot Number: 0022546131
• 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: 02/14/2019
• Patient Sequence Number: 1