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

Model Number M00573540

Device Problems Break (1069); Failure to Fold (1255)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2021

Event Type  malfunction  

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 Description

Note: this report pertains to the second of two jagtome rx 44 devices used during the same procedure.It was reported to boston scientific corporation that a jagtome rx 44 was used in the biliary during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, "the jagtome does not bend and tighten optimally." a second jagtome rx 44 was used; however, same thing happened, it did not bend and tighten optimally.Additionally, the cutting wire of the second jagtome rx 44 also broke.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was not completed due to this event as they could not perform sphincterotomy and considering the procedure time.The patient was rescheduled to have another ercp procedure.The exact date of the ercp is unknown.There were no patient complications reported as a result of this event and the patient outcome was reported to be fully recovered.

Manufacturer Narrative

Block h6 (device codes): medical device problem code a0401 captures the reportable event of cutting wire broken.Block h10: the returned jagtome rx 44 was analyzed, and a visual evaluation noted that the distal pierced hole (tome's extrusion) was torn, which displaced the cutting wire anchor from its original position and the wire anchor was still within the catheter, consistent with the findings when the device was observed under magnification.The tear was from the distal pierced hole to the brown band on the distal tip.The guidewire was also returned with no problems found.A functional evaluation was performed and the device did not bow due to the torn distal pierced hole, and it was observed that the anchor moved within the catheter.No other problems with the device were noted.The reported event of wire break was not confirmed.Upon analysis, the cutting wire was not broken.However, the reported event of unable to bow was confirmed due to the distal pierced hole being torn.This condition could have been caused by submitting the cutting wire to tension during the handle actuation and/or the device being energized during the handle actuation.Also, bowing the device without being completely out of the scope can also lead to a tear in the working length and displacement of the cutting wire.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.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

Note: this report pertains to the second of two jagtome rx 44 devices used during the same procedure.It was reported to boston scientific corporation that a jagtome rx 44 was used in the biliary during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, "the jagtome does not bend and tighten optimally." a second jagtome rx 44 was used; however, same thing happened, it did not bend and tighten optimally.Additionally, the cutting wire of the second jagtome rx 44 also broke.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was not completed due to this event as they could not perform sphincterotomy and considering the procedure time.The patient was rescheduled to have another ercp procedure.The exact date of the ercp is unknown.There were no patient complications reported as a result of this event and the patient outcome was reported to be fully recovered.

• Brand Name: JAGTOME RX 44
• Type of Device: 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: 12681945
• MDR Text Key: 278651519
• Report Number: 3005099803-2021-05430
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K013153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2024
• Device Model Number: M00573540
• Device Catalogue Number: 7354
• Device Lot Number: 0027173160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 11/30/2021
• Supplement Dates FDA Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1