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); Material Deformation (2976)

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

Event Date 04/24/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4). The returned microknife xl was analyzed, and a visual evaluation noted that the cutting wire was broken. The device was observed under magnification and the cutting wire was broken, blackened, and kinked/bent. These findings were consistent upon destructive analysis of the distal components after the device was cut. A functional evaluation was not performed due to the device condition. No other problems with the device were noted. The product analysis revealed that the cutting wire was broken, blackened, and kinked/bent. The cutting wire being blackened indicates that the device was energized. Based on the condition of the device, the problem found could have been caused if the device was energized prior to performing sphincterotomy which can compromise the cutting wire's integrity and cause premature cutting wire fatigue. The problem could have also been generated if the device was activated in an incorrect position or if in contact with other medical device. 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.

Event Description

It was reported to boston scientific corporation that a microknife xl was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021. During the procedure, "the needle did not externalize" when they pulled the device. It was reported that the device was exchanged with another device. It was unknown what device was used to complete the procedure. There were no reported patient complications as a result of this event. Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts. This event has been deemed a reportable event based on the investigation results: the cutting wire was broken. Please refer to 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: 12627598
• MDR Text Key: 278637976
• Report Number: 3005099803-2021-05177
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 10/13/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: M00532810
• Device Catalogue Number: 3281
• Device Lot Number: 0026067650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2020
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown