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

Model Number M00545840

Device Problem Break (1069)

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

Event Date 03/01/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an rx needle knife xl was used in the duodenum and sphincter of oddi during an endoscopic retrograde cholangiopancreatography (ercp) procedure.The exact procedure date was unknown.During the procedure, the rx needle knife xl was inserted through the endoscope.When the physician asked to extend the needle, nothing came out.The device was removed from the scope and when it was tried again to extend the needle, it was noticed that there was no needle present as the device had no needle at all.It was reported that there was no visible damage noted on the device.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Approximated based on the date the manufacturer became aware of the event.(b)(4).The complainant indicated that the device is not available for return; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Brand Name: RX NEEDLE KNIFE 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: 14091323
• MDR Text Key: 289261168
• Report Number: 3005099803-2022-01946
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729283799
• UDI-Public: 08714729283799
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K973826
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2022

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: 11/26/2023
• Device Model Number: M00545840
• Device Catalogue Number: 4584
• Device Lot Number: 0028456991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2021
• 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