MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOTOME RX 49; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00545160

Device Problems Break (1069); Use of Device Problem (1670)

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

Event Date 07/01/2022

Event Type  malfunction  

Manufacturer Narrative

Approximated based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.Initial reporter facility name: (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the device analysis, 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 49 was used in the papilla of vater during an endoscopic sphincterotomy (est) procedure.The exact procedure date was unknown.During the procedure, the cutting wire broke off from the catheter.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed using another of the same device.There were no patient complications reported as a result of this event.Note: it was reported that the exposed cutting wire had a little inside the endoscope when the device was energized.However, according to the instructions for use (ifu), "warning: verify that the cutting wire has exited the endoscope by visualizing it on the endoscope monitor.Failure to do so may result in contact between the cutting wire and the endoscope while electrical current is applied.This may cause grounding, which can result in patient injury, operator injury, a broken cutting wire, and/or damage to the endoscope.".

Manufacturer Narrative

Approximated based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.Block e1 (initial reporter facility name): national hospital organization kyoto medical center block h6 (device codes): medical device problem code a0401 captures the reportable event of cutting wire broken.Block h10: the returned autotome rx 49 was analyzed, and a visual evaluation noted that the returned portion of the distal tip of the cutting wire was broken and kinked.The device was observed under magnification, and the cutting wire was blackened and broken from the working length from the proximal pierced hole.No other problems with the device were noted.The reported event of cutting wire break was confirmed.Upon analysis, it was found 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.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.Based on the information that the exposed cutting wire had a little inside the endoscope when the device was energized; however, the instructions for use (ifu) indicates, "warning: verify that the cutting wire has exited the endoscope by visualizing it on the endoscope monitor.Failure to do so may result in contact between the cutting wire and the endoscope while electrical current is applied.This may cause grounding, which can result in patient injury, operator injury, a broken cutting wire, and/or damage to the endoscope." therefore, the most probable root cause for the reported problem of wire break will be documented as failure to follow instructions due to problems traced to the user not following the manufacturer's instructions.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use (ifu).

Event Description

It was reported to boston scientific corporation that an autotome rx 49 was used in the papilla of vater during an endoscopic sphincterotomy (est) procedure.The exact procedure date was unknown.During the procedure, the cutting wire broke off from the catheter.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed using another of the same device.There were no patient complications reported as a result of this event.Note: it was reported that the exposed cutting wire had a little inside the endoscope when the device was energized.However, according to the instructions for use (ifu), "warning: verify that the cutting wire has exited the endoscope by visualizing it on the endoscope monitor.Failure to do so may result in contact between the cutting wire and the endoscope while electrical current is applied.This may cause grounding, which can result in patient injury, operator injury, a broken cutting wire, and/or damage to the endoscope.".

• Brand Name: AUTOTOME RX 49
• 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: 15244001
• MDR Text Key: 299299946
• Report Number: 3005099803-2022-04658
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729415152
• UDI-Public: 08714729415152
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00545160
• Device Catalogue Number: 4516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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