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

Model Number	M00583140
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to be (b)(6) 2018 as no event date was reported.(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 truetome 44 was used in the main papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure.According to the complainant, during the procedure, the cutting wire broke.The physician was unable to remove the truetome 44 from the endoscope and so he had to remove the endoscope along with the truetome 44.The procedure was completed with a second truetome 44 to complete the procedure, using the same generator.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 truetome 44 was used in the main papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure.According to the complainant, during the procedure, the cutting wire broke.The physician was unable to remove the truetome 44 from the endoscope and so he had to remove the endoscope along with the truetome 44.The procedure was completed with a second truetome 44 to complete the procedure, using the same generator.There were no user injuries nor patient complications reported as a result of this event.
Additional Manufacturer Narrative
Date of event: date of event was approximated to be (b)(6) 2018 as no event date was reported.Device codes: the problem code 1069 captures the reportable event of cutting wire broken.Visual examination of the returned device revealed that the wire anchor was dislodged, broken, and blackened.Additionally, the distal pierced hole (tome's extrusion) was found torn and melted, therefore these conditions displaced the cutting wire causing the wire anchor to dislodged from the extrusion.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.Additionally, during manufacturing process the units are inspected in order to avoid or detect defects, however, there is no control in how devices are manipulated in the field.Therefore, the most probable root cause 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: TRUETOME JAG 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: 7928578
• Report Number: 3005099803-2018-60667
• Device Sequence Number: 19311418
• 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,Followup
• Report Date (Section B): 01/01/2019

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: 05/28/2020
• Device Model Number: M00583140
• Device Catalogue Number: 47405
• Device Lot Number: 0022181453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 01/01/2019
• Patient Sequence Number: 1