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

Model Number	M00560160
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	02/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 emdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an injection gold probe was used in the duodenum during an emergent gi bleed procedure performed on (b)(6) 2019.According to the complainant, the injection gold probe was broken inside the package.The complainant provided a photo of the device, which shows the distal tip was detached.This was discovered during the procedure, while the device was down the scope and inside the patient.The procedure was completed with another injection gold probe.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
(b)(4).Investigation results: an injection gold probe hemostasis catheter was received for analysis.A visual evaluation of the returned device revealed that the distal tip had broken off.The broken tip was not returned.No other issue was noted.Based on the evaluation of the returned device, the potential causes of the failure found is the condition of the adhesive used on the tip, however the base section of the tip is still attached to the catheter.This suggests that the adhesive was properly applied during manufacturing.Due to lack of details regarding event conditions, a clear conclusion about the cause of the reported event could not be determined.Therefore, the most probable cause of the reported event is cause not established.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.
Event or Problem Description
It was reported to boston scientific corporation that an injection gold probe was used in the duodenum during an emergent gi bleed procedure performed on (b)(6) 2019.According to the complainant, the injection gold probe was broken inside the package.The complainant provided a photo of the device, which shows the distal tip was detached.This was discovered during the procedure, while the device was down the scope and inside the patient.The procedure was completed with another injection gold probe.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: INJECTION 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: 8438573
• Report Number: 3005099803-2019-01052
• Device Sequence Number: 1795863
• Product Code: KNS
• UDI-Device Identifier: 08714729056508
• UDI-Public: 08714729056508
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K133933
• 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): 05/01/2019

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: 01/18/2020
• Device Model Number: M00560160
• Device Catalogue Number: 6016
• Device Lot Number: 21628911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1