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

Model Number M00560070

Device Problem Detachment Of Device Component (1104)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 02/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been received for analysis.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 a gold probe was used in the stomach during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2017.According to the complainant, during the procedure while scoping the patient for a gastrointestinal (gi) bleed, a piece of the gold probe tip detached from the catheter and remained inside the patient.A ct scan was performed on the same day following the procedure but the detached piece could not be visualized.The patient underwent an x-ray on (b)(6) 2017 and the detached piece was seen inside the patient's stomach.No attempts were made to retrieve the detached piece however.The procedure was completed with another of the same device using the same generator.There were no reported patient complication and the patient was stable after the procedure.Physician's assessed patient on wednesday ((b)(6) 2017) and noted the detached piece was making its way to the patient's small bowel as seen in the second x-ray performed on an unknown date.The patient is reported to be in stable condition.

Manufacturer Narrative

(b)(4).Investigation results: visual evaluation of the of the returned device showing the ceramic distal tip and was not returned.Transversal cut was applied showing the catheter with tread marks and presence of glue.In addition, internal electrical wires have evidence of welding process.The reported event of distal tip detached was confirmed.Due to anatomical/procedural factors encountered during the procedure, performance was limited.Therefore, the most probable root cause 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.A labeling review was performed and no anomalies were found.

Event Description

It was reported to boston scientific corporation that a gold probe was used in the stomach during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2017.According to the complainant, during the procedure while scoping the patient for a gastrointestinal (gi) bleed, a piece of the gold probe tip detached from the catheter and remained inside the patient.A ct scan was performed on the same day following the procedure but the detached piece could not be visualized.The patient underwent an x-ray on (b)(6) 2017 and the detached piece was seen inside the patient's stomach.No attempts were made to retrieve the detached piece however.The procedure was completed with another of the same device using the same generator.There were no reported patient complication and the patient was stable after the procedure.Physician's assessed patient on wednesday ((b)(6) 2017) and noted the detached piece was making its way to the patient's small bowel as seen in the second x-ray performed on an unknown date.The patient is reported to be in stable condition.

• 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: 6385276
• MDR Text Key: 69284744
• Report Number: 3005099803-2017-00557
• Device Sequence Number: 1
• Product Code: KNS
• 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
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/14/2018
• Device Model Number: M00560070
• Device Catalogue Number: 6007
• Device Lot Number: 20079932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2016
• 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): Other
• Patient Age: 90 YR