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

Model Number M00560150

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The returned injection gold probe needle was analyzed, and a visual evaluation noted that the tip was cracked and because of this condition the electrical test could not be performed.In addition, the catheter had a kink.Based on all available information and the condition of the returned device, the tip cracked and catheter kink most likely occurred as a result of force applied to the device and severe manipulation while being used.Based on the information available and the analysis performed, the most probable root cause for the encountered issue of distal tip cracked is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that an injection gold probe was used on (b)(6) 2020.According to the complainant, the gold probe did not cauterize.There were no known patient complications reported as a result of the 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: 10904839
• MDR Text Key: 218981123
• Report Number: 3005099803-2020-05174
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729056492
• UDI-Public: 08714729056492
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Model Number: M00560150
• Device Catalogue Number: 6015
• Device Lot Number: 0025433270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1