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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device problem code (b)(4).The complainant indicated that the device is not available for return; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 44 was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, as sphincterotomy was performed, the cutting wire severed from the center which prevented the procedure to be finished.It was reported that there was a risk of piercing the endoscope channel when the jagtome rx 44 was removed.There were no reported patient complications as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Note: images from the procedure were provided by the customer and showed the cutting wire was broken near the proximal pierce hole.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 44 was used in the papilla and bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, as sphincterotomy was performed, the cutting wire severed from the center.It was reported that there was a risk of piercing the endoscope channel when the jagtome rx 44 was removed.Additionally, no part of the cutting wire detached and fell into the patient.It was reported that the procedure was completed with this device.Note: images from the procedure were provided by the customer and showed the cutting wire was broken near the proximal pierce hole.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (device codes): medical device problem code a0401 captures the reportable event of cutting wire broken.Block h6 (evaluation conclusion codes): conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Additional information: b5, b7, d7a, h6 (impact codes), h8, h10.

• 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
• MDR Report Key: 12369881
• Report Number: 3005099803-2021-04442
• Device Sequence Number: 4814799
• Product Code: KNS
• UDI-Device Identifier: 08714729776673
• UDI-Public: 08714729776673
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K013153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2021

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: 06/26/2024
• Device Model Number: M00573060
• Device Catalogue Number: 7306
• Device Lot Number: 0027566792
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1