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

Model Number M00560150

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2016

Event Type  malfunction  

Manufacturer Narrative

Reported event of the tip detaching.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¿ device was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2016.According to the complainant, during preparation, the physician found that the gold tip of the injection gold probe¿ was detached.Reportedly, the device was never used on the patient.The procedure was complete with another injection gold probe¿.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¿ was found with a distal tip detached; however, the detached ceramic distal tip was not returned.Further evaluation revealed that the catheter was kinked near the handle and the needle was exposed and kinked.A transversal cut applied to the catheter revealed tread marks and the presence of glue.The complaint was confirmed; the device was returned with the distal tip detached.The observed failures of catheter kinked and needle kinked were likely due to manipulation of the device during unpacking and preparation.However, the review and analysis of all available information failed to indicate a root cause or probable root cause for the event of tip detached.Consequently, the most probable root cause for this event could not be determined.A review of the device history record confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.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 device was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2016.According to the complainant, during preparation, the physician found that the gold tip of the injection gold probe was detached.Reportedly, the device was never used on the patient.The procedure was complete with another injection gold probe.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: 5460483
• MDR Text Key: 39029356
• Report Number: 3005099803-2016-00462
• 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: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2017
• Device Model Number: M00560150
• Device Catalogue Number: 6015
• Device Lot Number: 18330815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2015
• 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