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

Model Number M00532810

Device Problems Break (1069); Use of Device Problem (1670); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual examination of the returned device revealed that the needle was found broken and the tip of the device damage and blackened.According to the product analysis, the cutting wire of the device product needle was found broken and the tip damage, so it is most likely that a peak of voltage could caused the failure noted if the guidewire was inside the device during cautery procedure and the guidewire used was not the recommended by directions for use (dfu).Therefore, the most probable cause of this complaint is failure to follow instructions since problems traced to the user not following the manufacturer's instructions.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release to distribution.

Event Description

It was reported to boston scientific corporation that a microknife xl was used in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) with pancreatic sphincterotome procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the boston scientific microknife xl was used along with a cook medical roadrunner guidewire connected to a bovi during the sphincterotomy, when the physician initiated the bovi, there was a spark at the surgical site and a small segment of guidewire was broken and retained inside the dorsal pancreatic duct.The procedure was completed with a different 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.

• 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 DE COSTA RICA S.R.L.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 9407169
• MDR Text Key: 189754719
• Report Number: 3005099803-2019-05883
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729172017
• UDI-Public: 08714729172017
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973826
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2019

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: 11/14/2020
• Device Model Number: M00532810
• Device Catalogue Number: 3281
• Device Lot Number: 0022945338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2018
• 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