MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) JAGTOME¿ RX 39; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00573100
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact event date is unknown; however, it was reported that the case was performed sometime in the second week of (b)(6).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 jagtome¿ rx 39 was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed.The exact procedure date is unknown; however, it was reported that the case was performed sometime in the second week of (b)(6).According to the complainant, during the procedure, the tome would not relax from the bowed position regardless of the effort of manipulating the handle.They left the guidewire in place and just removed the sphincterotome.They then loaded a 9mm-12mm extractor balloon and completed the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
Visual examination of the returned device found that the wire anchor dislodged, the distal pierced hole was torn, therefore, this last condition displaced the cutting wire causing the wire anchor to be dislodged from the extrusion.In addition, the cutting wire was kinked on the distal section, and the working length was twisted in multiple locations.The complaint was consistent with the reported event of wire won't release bow which could have been affected by dislodged wire anchor, and torn distal pierced hole.Based on the investigation and the receipt condition/functionality, the complaint conclusion investigation code selected for this complaint is "operational context¿ since it is most likely that due to anatomical and/or procedural factors encountered during the procedure, the performance of the device was limited.A dhr (device history record) review was performed and no deviation was found.A search of the complaint database confirmed that no similar complaints exist for the specified batch.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome¿ rx 39 was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed.The exact procedure date is unknown; however, it was reported that the case was performed sometime in the second week of february.According to the complainant, during the procedure, the tome would not relax from the bowed position regardless of the effort of manipulating the handle.They left the guidewire in place and just removed the sphincterotome.They then loaded a 9mm-12mm extractor balloon and completed the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: JAGTOME¿ RX 39
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7406408
• Report Number: 3005099803-2018-01021
• Device Sequence Number: 18978025
• Product Code: KNS
• UDI-Device Identifier: 08714729776536
• UDI-Public: 08714729776536
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Followup
• Report Date (Section B): 03/14/2018

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: 06/15/2020
• Device Model Number: M00573100
• Device Catalogue Number: 7310
• Device Lot Number: 20778703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Initial Date Received by Manufacturer: 03/14/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 04/09/2018
• Supplement Report FDA Received Date: 05/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1