MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) INJECTION GOLD PROBE¿; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00560150

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2015

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Reported event of the electrical connector broke in half.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 medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an injection gold probe¿ was used in the patient¿s stomach during hemostasis of bleeding gastric ulcer performed on (b)(6) 2015.According to the complainant, during the procedure, when injection gold probe¿ was removed from the scope the electrical connector broke in half.Reportedly, this had poked one of the nurses but no break on the skin was noted.The procedure was completed with another injection gold probe¿.No visible issue with the complaint device or the packaging prior to use.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.

Manufacturer Narrative

Visual analysis of the returned injection gold probe¿ revealed that the electrical connector is in good condition; however, the catheter was kinked near the electrical connector and middle of the device was also kinked with visible damage.The complaint was not confirmed.The failures found were probably caused due to the device manipulation during the procedure, since the device has evidence of use, and as per the complaint event description the issue occurred during procedure inside the patient.Due to anatomical/procedural factors encountered during the procedure, performance was limited.Therefore, the probable root cause classification is operational context.A review of the device history record was performed and no deviations were found.A search of the complaint database revealed that no other complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that an injection gold probe¿ was used in the patient¿s stomach during hemostasis of bleeding gastric ulcer performed on (b)(6) 2015.According to the complainant, during the procedure, when injection gold probe¿ was removed from the scope the electrical connector broke in half.Reportedly, this had poked one of the nurses but no break on the skin was noted.The procedure was completed with another injection gold probe¿.No visible issue with the complaint device or the packaging prior to use.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¿
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5331517
• MDR Text Key: 34525179
• Report Number: 3005099803-2015-03721
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/05/2017
• Device Model Number: M00560150
• Device Catalogue Number: 6015
• Device Lot Number: 17962470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2015
• 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