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 06/01/2015

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an injection gold probe device was used in the stomach during an esophagogastroduodenoscopy (egd) procedure on (b)(6) 2015.According to the complainant, after procedure, the physician noticed that the tip of the gold probe was missing upon removing the catheter from scope.The physician took the scope back down to the site of the ulcer and found the tip of the probe laying on mucosa.However, the physician decided to leave the tip and let it pass through the digestive system.The procedure was completed with this device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Reported event of the tip detaching.The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Moreover, the review and analysis of all available information fails to indicate a root cause or probable root cause.Therefore, the most probable root cause of this complaint is undeterminable.A review of the device history record (dhr) was performed and no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.

• 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: 4872587
• MDR Text Key: 6044065
• Report Number: 3005099803-2015-01752
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/17/2017
• Device Model Number: M00560150
• Device Catalogue Number: 6015
• Device Lot Number: 17713382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2015
• 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