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

Model Number M00560150

Device Problems Crack (1135); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/08/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0404 captures the reportable event of distal tip crack.

Event Description

It was reported to boston scientific corporation that an injection gold probe was used in the duodenum during a thermal coagulation procedure performed on (b)(6) 2023.During the procedure, the tip of the injection gold probe cracked at the targeted site inside the patient.The needle was still attached to the gold probe catheter, and nothing detached inside the patient.A non-bsc product was used to complete the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h2, h6: impact code has been corrected.Block h6: imdrf device code a0404 captures the reportable event of distal tip crack.Block h10: investigation results the returned injection gold probe device was received for analysis.A visual evaluation found that the tip of the device was detached from the working length and the working length was bent in different sections.Microscopic evaluation found no evidence of adhesive traces on the tip gold bands and one of the wires was not stripped.Furthermore, a destructive test was performed to verify the condition of the wires and it was found that one wire had no evidence of stripping.Based on the information available, working length bent likely occurred due to procedural factors such as lesion characteristics, handling of the device, or the technique used by the physician.Therefore, the most probable root cause of this issue found during analysis is "adverse event related to procedure".However, the most probable root cause for distal tip detached and the wire not stripped properly could not be established due to lack of evidence.The investigation findings did not lead to a clear conclusion about the cause of the reported event; therefore, "cause not established" was selected as the most probable cause for the complaint.An investigation is in place to address the problem.A labeling review was performed and, from the information available, this 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 was used in the duodenum during a thermal coagulation procedure performed on (b)(6) 2023.During the procedure, the tip of the injection gold probe cracked at the targeted site inside the patient.The needle was still attached to the gold probe catheter, and nothing detached inside the patient.A non-bsc product was used to complete the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Imdrf device code a0404 captures the reportable event of distal tip crack.Investigation results the injection gold probe was returned to boston scientific for laboratory analysis.Visual inspection found that the tip of the device was detached from the working length and the working length was bent in different sections.Microscopic inspection found no evidence of adhesive traces on the tip gold bands, and one of the wires was not stripped.Furthermore, a destructive test was performed to verify the condition of the wires and it was found that one wire had no evidence of stripping.Following receipt of this complaint event and returned product analysis, boston scientific initiated a non-conforming events prevention (ncep) to determine if any corrective actions were warranted.Boston scientific's investigation concluded that the referenced event was an isolated event due to human error.A review of the manufacturing process found that procedures were not followed accordingly as the returned device showed that the wire stripping was not performed according to procedure requirements and adhesive is missing from the tip gold bands.All product builders were made aware of the event, and the procedure was reviewed by all applicable product builders to heighten awareness of the requirements outlined in this manufacturing process.The ncep investigation was completed on october 3, 2023.Therefore, the most probable root cause of this issue found during analysis is "manufacturing deficiency".A labeling review was performed and, from the information available, this 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 was used in the duodenum during a thermal coagulation procedure performed on (b)(6) 2023.During the procedure, the tip of the injection gold probe cracked at the targeted site inside the patient.The needle was still attached to the gold probe catheter, and nothing detached inside the patient.A non-bsc product was used to complete the procedure.There were no patient complications reported as a result of this event.

• 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 CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17050097
• MDR Text Key: 316705151
• Report Number: 3005099803-2023-02810
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729056492
• UDI-Public: 08714729056492
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2023

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
• Device Operator: Health Professional
• Device Model Number: M00560150
• Device Catalogue Number: 6015
• Device Lot Number: 0029842855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 06/02/2023
• Supplement Dates Manufacturer Received: 09/14/2023; 10/13/2023
• Supplement Dates FDA Received: 10/11/2023; 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR