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

Model Number M00545180

Device Problems Device Dislodged or Dislocated (2923); Material Split, Cut or Torn (4008)

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

Event Date 03/14/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an autotome rx 44 was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, it was observed that the working length was torn and the wire anchor popped and became loosed.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: photos of the complaint device inside the package were provided by the customer and showed the wire anchor dislodged.

Manufacturer Narrative

Medical device problem code: (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.

Manufacturer Narrative

Block h6 (device codes): medical device problem code a051201 captures the reportable event of wire anchor dislodged.Block h10: the returned autotome rx 44 was analyzed, and a visual evaluation noted that the wire anchor got dislodged or dislocated from its distal pierced hole.The device was observed under magnification and the distal pierced hole was torn.The cutting wire was also blackened.These findings were consistent with the photos provided by the customer.Additionally, the working length was kinked at 58.5cm from the distal section to the proximal section.A dimensional inspection was performed between the distal pierced hole to the proximal pierced hole, and it was found within specification.No other problems with the device were noted.The reported event of wire anchor dislodged was confirmed.Upon analysis, it was found that the cutting wire anchor dislodged or dislocated from its distal pierced hole and the cutting wire was also blackened.The cutting wire being blackened indicates that the device was energized.The working length was also torn from the distal pierced hole, which could have been caused by submitting the cutting wire to tension during the handle actuation or if the device was energized during handle actuation.Also, bowing the device without being completely out of the scope can lead to a tear in the working length and displacing the cutting wire anchor from its position.Additionally, the working length was found kinked.This could have been generated during the handling and manipulation of the device during unpacking/prepping/testing.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

It was reported to boston scientific corporation that an autotome rx 44 was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2022.During the procedure, it was observed that the working length was torn and the wire anchor popped and became loosed.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: photos of the complaint device inside the package were provided by the customer and showed the wire anchor dislodged.

• 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: 13891025
• MDR Text Key: 288029635
• Report Number: 3005099803-2022-01606
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729444756
• UDI-Public: 08714729444756
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00545180
• Device Catalogue Number: 4518
• Device Lot Number: 0028679589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2022
• 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