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

Model Number M00545170

Device Problems Break (1069); Material Deformation (2976); Material Twisted/Bent (2981)

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

Event Date 05/06/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an autotome rx 44 was intended to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During preparation outside the patient, it was noticed that the tip of the device was crooked as it shifted to the right.The procedure was completed 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.This event has been deemed a reportable event based on the investigation results: the cutting wire was broken.

Manufacturer Narrative

(b)(4).The returned autotome rx 44 was analyzed, and a visual evaluation noted that the cutting wire was broken, blackened, and kinked.The device was observed under magnification, and the cutting wire was blackened and broken from the proximal pierced hole of the working length.There was no twist found on the working length.No other problems with the device were noted.The product analysis revealed that the cutting wire was broken, and blackened.The cutting wire being blackened indicates that the device was energized.Based on the condition of the device, the problem found could have been generated if there was contact between the device and the scope during energization or if the generator exceeded the maximum of voltage during the procedure.Also, energizing the device prior to performing sphincterotomy can compromise the cutting wire's integrity and cause a premature cutting wire fatigue.Additionally kinking/bending the cutting wire can lead to break it.It is most likely that procedural or anatomical factors encountered during the use of the device 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.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• 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: 15158073
• MDR Text Key: 300727472
• Report Number: 3005099803-2022-04336
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729444749
• UDI-Public: 08714729444749
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Physician
• Type of Report: Initial
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• 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: 0027575366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2021
• 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
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 75 KG