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

Model Number M00560070

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/07/2021

Event Type  Injury  

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 Description

Note: this report is two 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 Description

Note: this report is two 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.

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
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11306859
• MDR Text Key: 231126814
• Report Number: 3005099803-2021-00325
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729174691
• UDI-Public: 08714729174691
• Combination Product (y/n): N
• PMA/PMN Number: K970278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: M00560070
• Device Catalogue Number: 6007
• Device Lot Number: 0026437256
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 02/10/2021
• Supplement Dates Manufacturer Received: 04/07/2021
• Supplement Dates FDA Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention