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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION MICROKNIFE XL UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
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.
 
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Brand NameMICROKNIFE XL
Type of DeviceUNIT, 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 Key12673553
MDR Text Key277695106
Report Number3005099803-2021-05421
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K973826
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM00532810
Device Catalogue Number3281
Device Lot Number0027139536
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/17/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/14/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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