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

Model Number	M00573060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(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 on (b)(6) 2018 that a jagtome rx 44 was used in the bile duct during an endoscopic retrograde cholangiopancreatography procedure performed on (b)(6) 2018.According to the complainant, during the procedure, it was noticed that the jagtome rx 44 could easily be inserted through the working channel of the olympus duodenscope.As the physician tensed the papilla of the rx 44 papillotome for cutting, the cutting wire tore from the fixation.A cutting of the papilla was thus no longer possible.Since the papillotome could no longer be removed from the working channel, the doctor had to remove the duodenoscope together with the papillotome from the patient.To be able to remove the papillotome from the working channel, it had to be cut apart with a pair of pliers.The physician could then finish the procedure with another identical product.There were no injury nor patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: problem code 1069 captures the reportable event of wire broke.Block h10: visual examination of the returned device revealed that the cutting wire was broken and blackened.Additionally, the device was returned with the distal section cut.It is most likely that a peak of voltage could have caused the cutting wire to be broken and blackened.Furthermore, based on the event description, the distal section cut was performed by the user during the device removal.Therefore, the most probable cause of this complaint is adverse event related to procedure since it is most likely that the adverse event occurred during the procedure, and the device had no influence on event.A review of the device history record (dhr) was performed and no anomalies were observed.The review confirmed that the accepted device met all manufacturing specifications.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 on (b)(6) 2018 that a jagtome rx 44 was used in the bile duct during an endoscopic retrograde cholangiopancreatography procedure performed on (b)(6) 2018.According to the complainant, during the procedure, it was noticed that the jagtome rx 44 could easily be inserted through the working channel of the olympus duodenoscope.As the physician tensed the papilla of the rx 44 papillotome for cutting, the cutting wire tore from the fixation.A cutting of the papilla was thus no longer possible.Since the papillotome could no longer be removed from the working channel, the doctor had to remove the duodenoscope together with the papillotome from the patient.To be able to remove the papillotome from the working channel, it had to be cut apart with a pair of pliers.The physician could then finish the procedure with another identical product.There were no injury nor patient complications reported as a result of this event.

• Brand Name: JAGTOME 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 1242
• MDR Report Key: 8256392
• Report Number: 3005099803-2018-62487
• Device Sequence Number: 1960145
• Product Code: KNS
• UDI-Device Identifier: 08714729776673
• UDI-Public: 08714729776673
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

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: 07/08/2021
• Device Model Number: M00573060
• Device Catalogue Number: 7306
• Device Lot Number: 0022351998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1