MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) JAGWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number M0055658010

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a jagwire guidewire was used during a procedure {procedure date unknown}.According to the complainant, the guidewire had ¿an issue.¿ there were no patient complications reported as a result of this event.This event has been deemed reportable based on the investigation results: core wire tip exposed.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Investigation results of guidewire distal tip detached exposing the tip of the metal corewire.A visual examination of the guidewire revealed that the device was stuck inside the naviflex delivery system catheter.The ptfe jacket was peeled along the wire impeding the removal of wire from the catheter.The distal tip was detached exposing the tip of the metal corewire.No evidence of corewire fractured was found.The complaint is consistent with the return that there was an issue with the guidewire.The distal tip was detached exposing the tip of the metal corewire.Based on all gathered information the investigation fails to determine a definite root cause.

• Brand Name: JAGWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• 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: 4373728
• MDR Text Key: 16987903
• Report Number: 3005099803-2014-04124
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/24/2014

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
• Device Operator: Health Professional
• Device Model Number: M0055658010
• Device Catalogue Number: 5658-01S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2014
• Initial Date Manufacturer Received: 12/16/2014
• Initial Date FDA Received: 12/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1