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

Model Number	M00584060
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual examination of the returned device revealed that the working length was damaged, the distal pierced hole (tome's extrusion) was found torn, therefore this condition causing the wire anchor to be dislodged from the extrusion, these failure which could have affected the device ability to bow in a clinical setting, confirming the reported complaint.The anchor wire has a section broken, however this section was not returned for analysis and the cutting wire was observed blackened.According to the complaint information, the wire anchor and cutting wire has a section broken and blackened.It is most likely that a peak of voltage could have caused the failures noted.Therefore, a conclusion code of "cause traced to component failure" was assigned to the wire anchor has a section broken, since expected or random component failure without any design or manufacturing issue.However, the device received was found with distal pierce hole torn, this is evidence of that cutting wire anchor slipped causing the catheter to tear and causing the wire anchor to be dislodged from the extrusion.According with the information reviewed in this case there is no evidence of manufacturing issue or mishandle of the device.This type of damage is associated with a known design limitation of the device in which under certain scenarios of usage the catheter can tear, this is an anticipated failure mode within the risk documentation of the product.The most probable cause for the complaint will be assigned as design inadequate for purpose, since the problems traced to design/design features of the device that do not support or interfere with the intended purpose of the device.The dhr review was performed and no anomalies were observed, the review confirmed that the device met all manufacturing specifications and 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 44 was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during procedure, when they attempted to perform sphincterotomy, the cutting wire did not bow.Reportedly, there was no visible damage noted on the device.The procedure was completed with a new dreamtome rx 44.There were no user injuries nor patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results; cutting wire partially dislodged from the catheter.

• 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
• MDR Report Key: 8017630
• Report Number: 3005099803-2018-61046
• Device Sequence Number: 11088510
• Product Code: KNS
• UDI-Device Identifier: 08714729778288
• UDI-Public: 08714729778288
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K013153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2018

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: 06/21/2021
• Device Model Number: M00584060
• Device Catalogue Number: 47401
• Device Lot Number: 0022285854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1