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

Model Number M00532810

Device Problems Break (1069); Mechanical Problem (1384)

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

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18. (b)(4). The returned microknife xl was analyzed, and a visual evaluation noted that the device was in good condition without visual damage. The working length of the device was cut to expose the cutting wire and was observed under magnification and the cutting wire was broken, and the distal tip was blackened. The dimensional and functional evaluation were not performed due to the condition of the device. No other problems with the device were noted. The product analysis revealed that the cutting wire was broken. Upon analysis, it was found that the cutting wire was broken, and blackened including the distal tip, causing the needle unable to extend. Based on the condition of the device, the problem found could have been caused by maximum of voltage rating exceeded while energization or if the cutting wire was not in constant motion. 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 a microknife xl was used in the papilla during an endoscopic retrograde biliary drainage (erbd) procedure performed on (b)(6) 2021. During the procedure, the needle of the microknife xl could not extend. The procedure was completed with another of the same device. There were no patient complications reported as a result of this event. This event has been deemed a reportable event based on the investigation results: broken cutting wire. Please refer to block h10 for full investigation details.

• Brand Name: MICROKNIFE XL
• 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: 11633982
• MDR Text Key: 244415544
• Report Number: 3005099803-2021-01586
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K973826
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/08/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/04/2022
• Device Model Number: M00532810
• Device Catalogue Number: 3281
• Device Lot Number: 0025489578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial