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

Device Problem Break (1069)

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

Event Date 04/22/2022

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.It was reported that device used in the procedure was a hydratome.(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 a hydratome was used during an endoscopic retrograde cholangiopancreatography (ercp) with sphincterotomy procedure performed on (b)(6) 2022.During the procedure, while performing cautery, the cutting wire of the hydratome broke and was still hanging from the distal tip.It was unknown what device was used to complete the procedure; however, it was reported that the procedure was completed successfully.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

Event Description

It was reported to boston scientific corporation that a hydratome was used during an endoscopic retrograde cholangiopancreatography (ercp) with sphincterotomy procedure performed on (b)(6) 2022.During the procedure, while performing cautery, the cutting wire of the hydratome broke and was still hanging from the distal tip.It was unknown what device was used to complete the procedure; however, it was reported that the procedure was completed successfully.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.It was reported that device used in the procedure was a hydratome.Block h6: medical device problem code a0401 captures the reportable event of cutting wire broken.Block h10: the returned device was analyzed, and a visual evaluation noted that the cutting wire was broken and kinked.The device was observed under magnification and the cutting wire was broken, kinked, and blackened 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, kinked, 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.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 was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a device history review (dhr) on the most probable lots did not identify any anomalies or deviations within manufacturing/service processes that could have contributed to the event.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• 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: 14428869
• MDR Text Key: 292389716
• Report Number: 3005099803-2022-02721
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/18/2022
• Supplement Dates Manufacturer Received: 05/20/2022
• Supplement Dates FDA Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1