MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) RX NEEDLE KNIFE XL; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00545840

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a microknife rx 3l needle knife was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, there were no issues with needle movement (extension/retraction) when the device was tested before being put through the duodenoscope.However.During the procedure, inside the patient, when the handle was actuated to extend the needle, the needle did not come out in a controlled manner.The needle came out suddenly, and had to be partially retracted afterwards.The procedure was completed with the same device, and there were no patient complications reported as a result of this event.

• Brand Name: RX NEEDLE KNIFE XL
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6386455
• MDR Text Key: 69327459
• Report Number: 3005099803-2017-00721
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729283799
• UDI-Public: (01)08714729283799(17)20180826(10)19645246
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/26/2018
• Device Model Number: M00545840
• Device Catalogue Number: 4584
• Device Lot Number: 19645246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2016
• 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