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

Model Number M00560150

Device Problems Failure to Deliver Energy (1211); Defective Device (2588); Detachment of Device or Device Component (2907); Material Deformation (2976)

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

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0501 captures the investigation result of distal tip detached.Block h10: investigation results one injection gold probe needle was received for analysis.Visual analysis of the returned device found that the tip has no damage, but the working length was slightly bent and melted in the distal section near the proximal section of the tip.Microscope analysis confirmed the melting in the same area and also discovered that the proximal section of the ceramic tip was fractured.Additionally, during electrical analysis, it was observed that one of the bands did not conduct electricity.X-ray analysis further revealed that the tip's shape was asymmetrical.A destructive test was conducted and confirmed that the proximal section of the ceramic tip was fractured.No other device problems were noted.The reported event device failure to deliver energy was confirmed.Device analysis found the distal tip was fractured and the working length was melted and kinked during visual, microscope, electrical, x-ray and destructive tests.It is most likely that procedural factors such as, lesion characteristics, handling of the device, and the technique used by the physician could have resulted in the bend in the working length of the device.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is cause not established and the most probable root cause for the damage found during analysis (working length - bent/kinked) is adverse event related to procedure.

Event Description

It was reported to boston scientific corporation that an injection gold probe needle was used during a procedure performed on an unknown date.During the procedure, the bipolar catheter's tip became burnt and broke causing it to lose ability to transmit electrical current from the scalpel.The procedure was completed with another injection gold probe needle.It was not reported if there were no patient complications reported as a result of this event.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the distal tip was fractured.Please see block h10 for full investigation details.

Manufacturer Narrative

: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0501 captures the investigation result of distal tip detached.Block h10: investigation results one injection gold probe needle was received for analysis.Visual analysis of the returned device found that the tip has no damage, but the working length was slightly bent and melted in the distal section near the proximal section of the tip.Microscope analysis confirmed the melting in the same area and also discovered that the proximal section of the ceramic tip was fractured.Additionally, during electrical analysis, it was observed that one of the bands did not conduct electricity.X-ray analysis further revealed that the tip's shape was asymmetrical.A destructive test was conducted and confirmed that the proximal section of the ceramic tip was fractured.No other device problems were noted.The reported event device failure to deliver energy was confirmed.Device analysis found the distal tip was fractured and the working length was melted and kinked during visual, microscope, electrical, x-ray and destructive tests.It is most likely that procedural factors such as, lesion characteristics, handling of the device, and the technique used by the physician could have resulted in the bend in the working length of the device.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is cause not established and the most probable root cause for the damage found during analysis (working length - bent/kinked) is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that an injection gold probe needle was used during a procedure performed on an unknown date.During the procedure, the bipolar catheter's tip became burnt and broke causing it to lose ability to transmit electrical current from the scalpel.The procedure was completed with another injection gold probe needle.It was not reported if there were no patient complications reported as a result of this event.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the distal tip was fractured.Please see block h10 for full investigation details.

• Brand Name: INJECTION 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
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17666267
• MDR Text Key: 322450579
• Report Number: 3005099803-2023-04562
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729056492
• UDI-Public: 08714729056492
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K133933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00560150
• Device Catalogue Number: 6015
• Device Lot Number: 0029536087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1