MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER TRUETOME¿ JAG 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00583140
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual evaluation of the returned device found that the cutting wire broken, kinked and blackened.Moreover, the device working length was twisted and kinked.Additionally, the working length was found cut near the distal end of the heat shrink.A functional inspection could not be performed due to the condition of the returned device.The complaint was consistent with the reported event of cutting wire broken.Most likely, the defect was due to anatomical/procedural factors encountered during the procedure, therefore, the complaint conclusion investigation code for the complaint is operational context.A dhr (device history record) review was performed and no deviation was found.
Event or Problem Description
It was reported to boston scientific corporation that a truetome¿ jag 44 was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) examination during sphincterotomy (es) procedure.According to the complainant, during the procedure, the cut wire broke.Because the cut wire was broken, it was not possible to remove the truetome from the duodenoscope.The whole system was removed from the patient in order to remove the truetome from the scope.The procedure was completed with a second truetome.There were no patient complications reported as a result of this event.

• Brand Name: TRUETOME¿ JAG 44
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7131586
• Report Number: 3005099803-2017-03879
• Device Sequence Number: 19282438
• Product Code: KNS
• UDI-Device Identifier: 08714729858683
• UDI-Public: 08714729858683
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122203
• 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
• Report Date (Section B): 11/21/2017

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: 05/09/2019
• Device Model Number: M00583140
• Device Lot Number: 20622177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1