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

Model Number M00560071

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2016

Event Type  Injury  

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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that a gold probe was used during a broch debridement procedure performed on (b)(6) 2016.According to the complainant, during the procedure the tip of the gold probe broke and was retrieved by the physician.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.

Event Description

It was reported to boston scientific corporation that a gold probe was used during a broch debridement procedure performed on (b)(6) 2016.According to the complainant, during the procedure the tip of the gold probe broke and was retrieved by the physician.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.Additional information received on december 05, 2016 confirming that the gold probe was used in the lungs.

Manufacturer Narrative

Investigation results: visual evaluation of the of the returned ceramic distal tip showed evidence that electrical wires were correctly place on each gold band.The reported event of distal tip detached was confirmed.As specified in the dfu, the gp devices are indicated for ¿use in transendoscopic electrohemostasis of visible bleeding and non-bleeding sites in the gastrointestinal tract including the esophagus, stomach, duodenum, and colon.¿ it was reported that the device was used in the lungs.Therefore the most probable root cause is use/user error.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.A labeling review was performed and there is information to determine that the device was not used in accordance with the labeling.

Event Description

It was reported to boston scientific corporation that a gold probe was used during a broch debridement procedure performed on (b)(6) 2016.According to the complainant, during the procedure the tip of the gold probe broke and was retrieved by the physician.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.Additional information received on december 05, 2016 confirming that the gold probe was used in the lungs.

• Brand Name: 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: 6117445
• MDR Text Key: 60544184
• Report Number: 3005099803-2016-03508
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729071013
• UDI-Public: (01)08714729071013(17)20170608(10)18075840
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970278
• 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,Followup
• Report Date: 10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2017
• Device Model Number: M00560071
• Device Catalogue Number: 6007-05
• Device Lot Number: 18075840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 49 YR