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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

(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 microknife xl was used in the duodenal papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the device was inserted into the scope and it was found that the needle would not extend.Additionally, the "middle part" of the cutting wire was found broken.Reportedly, no part of the cutting wire detached and fell into the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6 (device codes): the problem code a0401 captures the reportable event of cutting wire broken.Block h10: the returned microknife xl was analyzed, and a visual evaluation noted that the wire was broken and bent inside the body of the handle which caused the needle unable to extend.The device was observed under magnification and the cut of the cutting wire was not smooth.Additionally, under electron microscopy inspection, the cutting wire was observed with fracture features.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, and bent inside the body of the handle which caused the needle unable to extend.Per scanning electron microscopy (sem) analysis severe bending of the wires into a sharp radius, wrinkling and microcracks are evidence of severe bending back and forth, ductile dimple rupture on all fracture surfaces in the middle area indicates overload fracture of a ductile wire material that is normal and not brittle.Ratchet marks or ridges on the fracture surfaces in the middle area, which indicate the fracture occurred progressively, as the wire was bent sharply and straightened multiple times prior to the final separation.For reasons that are unknown based on the information examined in this sem analysis, the wire did not move distally and proximally when the handle was actuated, as intended.The wire herniated out of its normal path, bowing and bending out of the window in the handle when the handle was squeezed, and being pulled back straight when the handle was retracted.Based on all gathered information and the analysis performed to the returned product, it was concluded that the investigation conclusion code of this event is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.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 in the duodenal papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(4) 2020.According to the complainant, during the procedure, the device was inserted into the scope and it was found that the needle would not extend.Additionally, the "middle part" of the cutting wire was found broken.Reportedly, no part of the cutting wire detached and fell into the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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
• MDR Report Key: 11008590
• MDR Text Key: 226645370
• Report Number: 3005099803-2020-05960
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729172017
• UDI-Public: 08714729172017
• Combination Product (y/n): N
• PMA/PMN Number: K973826
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2022
• Device Model Number: M00532810
• Device Catalogue Number: 3281
• Device Lot Number: 0025531766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 77