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	10/04/2018
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 for a sphincterotomy on (b)(6) 2018.According to the complainant, during the procedure, it was noticed that after easy catheterization, the cutting wire broke and came out of its place.There were no reported patient complications.
Event or Problem Description
It was reported to boston scientific corporation that a dreamtome rx 49 was used for a sphincterotomy on october 4, 2018.According to the complainant, during the procedure, it was noticed that after easy catheterization, the cutting wire broke and came out of its place.There were no reported patient complications.
Additional Manufacturer Narrative
H6: problem code 1069 captures the reportable event of wire broke.Block h10: visual evaluation of the returned device found the unit returned has the cutting wire broken and blackened, consequently, confirming the reported complaint.According to the product analysis, the cutting wire of the returned product was found to be broken and blackened, so it is most likely that a peak of voltage could have caused the failures noted.Therefore, it was concluded that the investigation conclusion code of this event is "cause traced to component failure" since the failure was an expected or random component failure without any design or manufacturing issue.A search of the complaint database revealed that no other complaints exist for the specified lot.-¿the device history record review found the device met all manufacturing specifications.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/19/2018 11:15 pm ct.The report number is being corrected from: 3005099803-2018-61978 to: 3005099803-2018-61062.

• 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: 8035545
• Report Number: 3005099803-2018-61062
• Device Sequence Number: 1435501
• 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): 01/22/2019

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: 07/02/2021
• Device Model Number: M00584010
• Device Catalogue Number: 8401
• Device Lot Number: 0022334222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 01/22/2019
• Patient Sequence Number: 1