MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GOLD PROBE 350CM; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00560220
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a gold probe was used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, at some point when the device was pulled back into the scope, the distal tip broke off.The procedure was completed using this device.The complainant reported the distal tip was believed to have fallen off inside the scope.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Event or Problem Description
It was reported to boston scientific corporation that a gold probe was used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, at some point when the device was pulled back into the scope, the distal tip broke off.The procedure was completed using this device.The complainant reported the distal tip was believed to have fallen off inside the scope.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
F10: device problem code 2907 captures the reportable event of distal tip detached.H10: investigation result a gold probe hemostasis catheter was received for analysis.A visual evaluation of the returned device revealed that the distal tip was detached and that there was a catheter kink in the distal section.The gold distal tip was not returned for analysis.The distal section of the catheter was cut transversely and examined.Internal treadmarks and glue were present, indicating the tip was properly assembled.Based on the evaluation of the returned device, the detachment of the distal tip may have been due to excessive manipulation of the device by the user.The kink in the catheter may have been caused by excessive interaction with other devices during the procedure.Therefore, the most probable cause of the reported event is adverse event related to procedure.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 for distribution.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/19/2018 04:29 pm ct.The report number is being corrected from: 3005099803-2018-62060 to: 3005099803-2018-61311.

• Brand Name: GOLD PROBE 350CM
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 8053404
• Report Number: 3005099803-2018-61311
• Device Sequence Number: 1653478
• Product Code: KNS
• UDI-Device Identifier: 08714729099574
• UDI-Public: 08714729099574
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K970278
• 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,Followup
• Report Date (Section B): 01/23/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/23/2020
• Device Model Number: M00560220
• Device Catalogue Number: 6022
• Device Lot Number: 0022163837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Initial Date Received by Manufacturer: 10/16/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1