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

Model Number M00560150

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received but an evaluation has not yet been performed; therefore, a failure analysis is not available.If there is any further relevant information received, a supplemental medwatch report will be filed.At this time, we are unable to determine the relationship between the device and the cause for the event.

Event Description

It was reported to boston scientific corporation that an injection gold probe device was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in (b)(6) 2015.According to the complainant, during the withdrawal of the device from the patient, the tip of the injection gold probe device detached from the catheter.The tip of the injection gold probe was left inside the patient and is expected to pass naturally.After the device was removed from the scope, a piece of wire (the hypotube) came out of the scope.This piece did not fall into the patient.The procedure was completed 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 stable.

Manufacturer Narrative

A visual examination of the returned device revealed that the ceramic distal tip was detached and was not returned.The needle was kinked and exposed, and the catheter was kinked near the electrical connector.A piece of the hypotube was returned.The complaint was confirmed.The investigation concluded that this complaint is associated with a product that meets design and manufacture specifications but 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; no anomalies were noted.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 endoscopic retrograde cholangiopancreatography (ercp) procedure in (b)(6) 2015.According to the complainant, during the withdrawal of the device from the patient, the tip of the injection gold probe device detached from the catheter.The tip of the injection gold probe was left inside the patient and is expected to pass naturally.After the device was removed from the scope, a piece of wire (the hypotube) came out of the scope.This piece did not fall into the patient.The procedure was completed 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 stable.

• 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: 5148696
• MDR Text Key: 28253408
• Report Number: 3005099803-2015-02898
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K961349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2017
• Device Model Number: M00560150
• Device Catalogue Number: 6015
• Device Lot Number: 17827250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2015
• 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