MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGTOME RX 39; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00573080
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date (b)(6) 2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 39 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure.The exact procedure date is unknown.During the procedure, when the physician pulled out the device, it was noticed that the cutting wire broke.It was reported that the cutting wire was stuck behind the elevator and that they could not find the wire even after x-ray was performed which showed no cutting wire.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.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 39 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on april 6, 2021.During withdrawal, when the physician pulled out the device, it was noticed that the cutting wire broke.It was reported that the cutting wire was stuck behind the elevator and that they could not find the wire even after x-ray was performed which showed no cutting wire.The procedure was completed with the original device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Additional information: b3, b5, d7a, e1 (initial reporter first name), h6 (patient codes), h6 (impact codes), h8.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 device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

• Brand Name: JAGTOME RX 39
• 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: 11759886
• Report Number: 3005099803-2021-01970
• Device Sequence Number: 14575868
• Product Code: KNS
• UDI-Device Identifier: 08714729776642
• UDI-Public: 08714729776642
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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: 05/02/2021
• Device Model Number: M00573080
• Device Catalogue Number: 7308
• Device Lot Number: 0022074161
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1