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

Model Number M00560150

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 duodenum during a hemostasis of duodenal ulcer performed on (b)(6) 2016.According to the complainant, the procedure was completed with this device; however, after the procedure, the electrical connector of the injection gold probe¿ detached from the catheter when it was being disconnected from the generator.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 stable.

Manufacturer Narrative

Visual analysis of the returned injection gold probe¿ revealed that the electrical connector was broken and the distal tip has an evidence of burn.Further evaluation of the electrical connector found that it has evidence that it was correctly assembled according to the main assembly procedure, also the internal wires were found broken, and both have evidence of welding process.The complaint was confirmed; the device was returned with the electrical connector was detached.The observed failures found were probably caused by an excessive force applied to the device during unplug.However, due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.Therefore, the most probable root cause classification for the reported failure is operational context.A review of the device history record (dhr) was performed; no anomalies were noted.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 duodenum during a hemostasis of duodenal ulcer performed on (b)(6) 2016.According to the complainant, the procedure was completed with this device; however, after the procedure, the electrical connector of the injection gold probe¿ detached from the catheter when it was being disconnected from the generator.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 stable.

• 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: 5584803
• MDR Text Key: 42944650
• Report Number: 3005099803-2016-01041
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K961349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/01/2016

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 Expiration Date: 07/21/2017
• Device Model Number: M00560150
• Device Catalogue Number: 6015
• Device Lot Number: 18221945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2016
• Initial Date FDA Received: 04/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2015
• 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
• Patient Age: 48 YR
• Patient Weight: 51