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

Model Number	M00583140
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 truetome jag 44 was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, after the physician inserted the jagwire guidewire into the cbd, the truetome was connected to the generator for sphincterotomy.However, during sphincterotomy, the cutting wire was broken.It was reported that the wire anchor had dislodged from the catheter.Additionally, no part of the cutting wire detached and fell into the patient.The physician removed the device and the procedure was completed with another of the same device.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 stable.
Event or Problem Description
It was reported to boston scientific corporation that a truetome jag 44 was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, after the physician inserted the jagwire guidewire into the cbd, the truetome was connected to the generator for sphincterotomy.However, during sphincterotomy, the cutting wire was broken.It was reported that the wire anchor had dislodged from the catheter.Additionally, no part of the cutting wire detached and fell into the patient.The physician removed the device and the procedure was completed with another of the same device.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 stable.
Additional Manufacturer Narrative
Block h6 (device codes): medical device problem code a051201 captures the reportable event of wire anchor dislodged.Block h10: the returned truetome jag 44 was analyzed, and a visual evaluation noted that the cutting wire anchor was dislodged/dislocated from the distal pierced hole, consistent with the findings when the device was observed under magnification.Additionally, the cutting wire was blackened, and the working length was also torn from the distal pierced hole.No other problems with the device were noted.The reported event of cutting wire anchor dislodged was confirmed.Upon analysis, it was found that the cutting wire anchor was dislodged/dislocated.The cutting wire was blackened with no evidence of a broken or missing wire.The cutting wire being blackened indicates that the device was energized.The working length was also torn at the distal pierced hole and this could have been caused by submitting the cutting wire to tension during the handle actuation.In addition, with the possibility of the device being energized during the handle actuation, the analyzed problem could happen.Also, bowing the device without being completely out of the scope can lead to a tear in the working length, displacing the cutting wire anchor from its position.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13308854
• Report Number: 3005099803-2022-00141
• Device Sequence Number: 3424171
• Product Code: KNS
• UDI-Device Identifier: 08714729858683
• UDI-Public: 08714729858683
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K122203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2022

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: 05/27/2023
• Device Model Number: M00583140
• Device Catalogue Number: 8314
• Device Lot Number: 0027396441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/27/2021
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 77 KG