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

Model Number M00545170

Device Problems Crack (1135); Device Dislodged or Dislocated (2923)

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

Event Date 09/21/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an autotome rx 44 was used in the duodenal papilla during an endoscopic retrograde cholangiopancreatography (ercp) bile duct lithotomy procedure performed on (b)(6), 2023.During the procedure, it was noticed that the tip if the device was fractured and the cutting wire anchor was dislodged.It was reported that no part of the cutting wire detached and fell into the patient.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.

Manufacturer Narrative

Block a4: the patient's weight is 57.5 kg.Block h6: imdrf device code a051201 captures the reportable event of cutting wire anchor dislodged.

Manufacturer Narrative

Block a4: the patient's weight is 57.5 kg.Block h6: imdrf device code a051201 captures the reportable event of cutting wire anchor dislodged.Block h10: the returned autotome rx 44 was analyzed, and a visual evaluation noted that the cutting wire anchor was dislodged from the distal pierce hole.The working length was found free from kinks and bends.The device was observed under magnification, and the distal pierce hole was torn, the cutting wire was blackened and kinked, and the tip was cracked.No other problems with the device were noted.The reported event cutting wire anchor dislodged was confirmed.Upon analysis, it was found that the cutting wire anchor was dislodged from the distal pierce hole which was also torn, the cutting wire was blacked and kinked, and the tip was cracked.Based on the condition of the returned device, it could have been caused by submitting the cutting wire to tension during the handle actuation, and possibly the device being energized during the handle actuation, or bowing the device without being completely out of the scope which can displace/dislodge the cutting wire anchor from its position.Additionally, handling and manipulation of the device during its use, and the interaction of the device with the scope can lead to kink the cutting wire.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.

Event Description

It was reported to boston scientific corporation that an autotome rx 44 was used in the duodenal papilla during an endoscopic retrograde cholangiopancreatography (ercp) bile duct lithotomy procedure performed on (b)(6) 2023.During the procedure, it was noticed that the tip if the device was fractured and the cutting wire anchor was dislodged.It was reported that no part of the cutting wire detached and fell into the patient.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.

• 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: 17913702
• MDR Text Key: 325698583
• Report Number: 3005099803-2023-05466
• 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,Followup
• Report Date: 12/14/2023

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 Model Number: M00545170
• Device Catalogue Number: 4517
• Device Lot Number: 0030208672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2023
• Initial Date FDA Received: 10/11/2023
• Supplement Dates Manufacturer Received: 11/20/2023
• Supplement Dates FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2022
• 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
• Patient Age: 48 YR
• Patient Sex: Male