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

Model Number	M00560160
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Investigation findings of gold probe tip detached.Reported event of the needle coming out through the catheter.Investigation results: a visual evaluation of the returned injection gold probe revealed that the distal tip was detached and catheter was kinked near the electrical connector.Further evaluation found the needle had punctured through the sheath.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 and no deviations were found.A search of the complaint database revealed that no other complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that an unknown event occurred with an injection gold probe¿ with an while being used in the colon descendens during a procedure performed on (b)(6) 2016.There were no patient complications reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.The investigation found the distal tip of the gold probe was detached, this is now deemed an mdr reportable event.

• Brand Name: INJECTION GOLD PROBE¿
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6248148
• Report Number: 3005099803-2016-04117
• Device Sequence Number: 1477943
• Product Code: KNS
• UDI-Device Identifier: 08714729056508
• UDI-Public: (01)08714729056508(17)20170415(10)17896258
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K961349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/15/2017
• Device Model Number: M00560160
• Device Catalogue Number: 6016
• Device Lot Number: 17896258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2016
• Initial Report FDA Received Date: 01/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1