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

Model Number M00556561

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2014

Event Type  malfunction  

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report #3005099803-2014-03916 and 3005099803-2014-03917 for the other associated device information.It was reported to boston scientific corporation that a jagwire guidewire was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2014.According to the complainant, during the procedure, while cannulating the bile duct using a sphincterotome, the hydrophilic tip of the jagwire guidewire detached inside the patient exposing the tip of the metal corewire.The guidewire was removed and a second jagwire guidewire was used, however, the hydrophilic tip detached inside the patient exposing the tip of the metal corewire.The procedure was completed with a different device.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 fine.

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over 18 years old.Reported event of guidewire distal tip detached exposing the tip of the metal corewire.The device has not been received for analysis.Upon receipt and 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.

Manufacturer Narrative

A visual examination of the guidewire revealed that the distal tip was detached exposing the tip of the metal corewire, approximately 2.3cm.Presence of adhesive remnants were found indicating that the pebax was properly attached to the corewire.No evidence of corewire fractured.The complaint is consistent with the return that 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.A dhr (device history record) review was performed and no deviation was found.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report #3005099803-2014-03916 and 3005099803-2014-03917 for the other associated device information.It was reported to boston scientific corporation that a jagwire guidewire was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2014.According to the complainant, during the procedure, while cannulating the bile duct using a sphincterotome, the hydrophilic tip of the jagwire guidewire detached inside the patient exposing the tip of the metal corewire.The guidewire was removed and a second jagwire guidewire was used, however, the hydrophilic tip detached inside the patient exposing the tip of the metal corewire.The procedure was completed with a different device.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 fine.

• 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: 4333246
• MDR Text Key: 5246973
• Report Number: 3005099803-2014-03917
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2014

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 Expiration Date: 08/14/2015
• Device Model Number: M00556561
• Device Catalogue Number: 5656
• Device Lot Number: 15458192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2015
• Initial Date FDA Received: 12/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2012
• 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