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 02/18/2024

Event Type  malfunction  

Manufacturer Narrative

Block e1: (b)(6).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 for a gastroenteric ulcer with bleeding during a procedure performed on (b)(6) 2024.During the procedure, it was reported that the distal gold tip was cracked.The procedure was completed using a non-boston scientific thermal biopsy forceps device.There were no patient complications as a result of this event.

Manufacturer Narrative

Block e1: healthcare facility name: (b)(6).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 analyzed and found that the catheter was kinked, and the tip was detached from the catheter.In addition, the tip was blackened, and the catheter had adhesive residues.The reported event of distal tip crack was not confirmed.It was found that the catheter was kinked, and the tip was detached from the catheter.These problems could have been due to procedure or anatomical factors during the use of the device.The tip detachment could have been due to contact between the device and the scope during energization or if the device exceeded the maximum voltage during the procedure.Also, the tip was blackened, and the catheter had residues of adhesive indicating that the tip was correctly assembled.Based on all available information, adverse event related to procedure was selected as the most probable cause.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 for a gastroenteric ulcer with bleeding during a procedure performed on (b)(6) 2024.During the procedure, it was reported that the distal gold tip was cracked.The procedure was completed using a non-boston scientific thermal biopsy forceps device.There were no patient complications 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: 18908485
• MDR Text Key: 337743512
• Report Number: 3005099803-2024-00984
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729056492
• UDI-Public: 08714729056492
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 05/08/2024

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: 0031164318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 04/16/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2023
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 75 KG