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

Model Number	M00560070
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental emdr will be filed.
Event or Problem Description
Note: this report is one of two complaints that pertain to the same event.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) 2021.According to the complainant, during the procedure, the first gold probe tip fell off and the same happened to the second needle after applying gold probe to bleeding ampulla.The tip was retrieved by pulling through scope with rat tooth/alligator forceps.The procedure was completed with another gold probe.There were no patient complications reported as a result of this event.
Event or Problem Description
Note: this report is one of two complaints that pertain to the same event.It was reported to boston scientific corporation that a gold probe was used in the doudenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the first gold probe tip fell off and the same happened to the second needle after applying gold probe to bleeding ampulla.The tip was retrieved by pulling through scope with rat tooth/alligator forceps.The procedure was completed with another gold probe.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b1, b2 and h1 has been updated.Block h6: device code a0501 captures the reportable event of distal tip detached.Evaluation conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental emdr will be filed.

• Brand Name: GOLD PROBE
• 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: 11306875
• Report Number: 3005099803-2021-00324
• Device Sequence Number: 3287173
• Product Code: KNS
• UDI-Device Identifier: 08714729174691
• UDI-Public: 08714729174691
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K970278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/27/2022
• Device Model Number: M00560070
• Device Catalogue Number: 6007
• Device Lot Number: 0026430711
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention