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); Material Integrity Problem (2978)

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

Event Date 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The returned microknife xl was analyzed, and a visual evaluation noted that the cutting wire was broken and kinked/bent on the handle section, consistent with the findings when the device was observed under magnification.It was also found that the handle area was kinked/bent.Upon destructive analysis of the device, wherein the device was torn to inspect the internal components and compared with a good condition sample, a gap was observed.Also, the cutting wire was kinked/bent on the threaded area of the hypotube.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 at the handle section.Based on the condition of the device, the problem found could have been caused due to procedural factors encountered during procedure, affecting the device performance and integrity.It is possible that if the cutting wire was activated, there was resistance from the kinked section that was observed on the handle causing fatigue and the cutting wire to break.Additionally, the cutting wire was kinked/bent on the threaded area of the hypotube.This condition could have been generated after the manufacturing process.Based on all gathered information and since the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event, the most probable root cause of this complaint is cause not established.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 intended to be used in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During preparation outside the patient, the needle did not come out from the sheath.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: the cutting wire was broken.

• 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: 12673553
• MDR Text Key: 277695106
• Report Number: 3005099803-2021-05421
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729172017
• UDI-Public: 08714729172017
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K973826
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2021

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 Expiration Date: 04/14/2023
• Device Model Number: M00532810
• Device Catalogue Number: 3281
• Device Lot Number: 0027139536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2021
• Initial Date FDA Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2021
• 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: 64 YR