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

Model Number	M00561270
Medical Device Problem Codes	Failure to Deliver Energy (1211); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an active cord was used during a polypectomy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the active cord failed to transmit current when it was used to coagulate and prevent bleeding post polypectomy.The generator was on the proper settings and they have not had any issue before.Reportedly, the procedure was completed with no further devices used.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine.Note: according to the complainant, two gold probe units and an active cord unit was attempted to use to coagulate and prevent bleeding post polypectomy.However, per the gold probe directions for use, the device is intended to be used with a bipolar electrosurgical generator or a bipolar cable adapter.The active cord is intended to be used with monopolar devices.

• Brand Name: ACTIVE CORD
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7947696
• Report Number: 3005099803-2018-60753
• Device Sequence Number: 2255930
• Product Code: KNS
• UDI-Device Identifier: 08714729053361
• UDI-Public: 08714729053361
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: M00561270
• Device Catalogue Number: 50975
• Device Lot Number: 0018134623
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1