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

Model Number M00545170

Device Problems Failure to Fold (1255); Positioning Problem (3009)

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

Event Date 11/19/2021

Event Type  malfunction  

Manufacturer Narrative

This event was reported by the distributor.The physician is: (b)(4).(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

It was reported to boston scientific corporation that an autotome rx 44 was used in the papilla during an endoscopic sphincterotomy(est) procedure performed on (b)(6) 2021.During the procedure, initially when this device exited the scope, the orientation of the catheter tip and the cutting wire were both correct and they were able to cannulate into the bile duct.However, when they performed est, it was noticed that the direction of the cutting wire was in an abnormal orientation.They tried to grasp the handle to bow the device but they could not stretch it.Est was performed in the same manner and the procedure was completed.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that an autotome rx 44 was used in the papilla during an endoscopic sphincterotomy(est) procedure performed on (b)(6)2021.During the procedure, initially when this device exited the scope, the orientation of the catheter tip and the cutting wire were both correct and they were able to cannulate into the bile duct.However, when they performed est, it was noticed that the direction of the cutting wire was in an abnormal orientation.They tried to grasp the handle to bow the device but they could not stretch it.It was reported that there was no visible damage to the device prior to putting it through the scope and after the issue occurred.Est was performed in the same manner and the procedure was completed.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Section e: this event was reported by the distributor.The physician is: (b)(6) block h6 (device codes): medical device problem code a1502 captures the reportable event of incorrect cutting wire orientation.Block h10: the returned autotome rx 44 was analyzed, and a visual evaluation noted that the cutting wire was blackened and the working length was torn at the distal section.The torn area had evidence of melting.A functional evaluation was performed by introducing the device into the scope using short and deliberate movements and it was noted that the initial orientation of the device was correct when the distal tip was extended approximately 25mm past the elevator of the duodenoscope.Additionally, bowing test was perform outside and inside the scope, the device bowed and returned from bowed position as intended.No other problems with the device were noted.The reported event was not confirmed.The orientation of the device was correct when it exited the scope.Upon analysis, it was found that the cutting wire was blackened and the distal section of the working length was slightly torn.Cutting wire blackened indicates that the device was energized during its use and contact with the tissue could have caused the blackened appearance.Also, tearing in the working length with evidence of melting suggest that the component was submitted to heat and it could have torn the distal section of the working length, which could have affected the overall performance of the device at the moment to bow the device.It is most likely that procedural or anatomical factors encountered during procedure could have affected the device performance and its integrity.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.Block h11 (correction): block b5 and e1 (initial reporter zip/post code) has been corrected.

• Brand Name: AUTOTOME 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: 13005730
• MDR Text Key: 285832036
• Report Number: 3005099803-2021-06409
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729444749
• UDI-Public: 08714729444749
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00545170
• Device Catalogue Number: 4517
• Device Lot Number: 0027862948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2021
• 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