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

Model Number M00556581

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a jagwire guidewire was used during an endoscopic retrograde cholangiopancreatography procedure performed on (b)(6), 2014.According to the complainant, during the procedure, the ultratome xl was inserted through the non bsc duodenoscope for cannulation.Once the tip of the ultratome xl was inside the common bile duct, the jagwire guidewire was inserted into the ultratome xl.When the guidewire reached the ampulla, it was noticed that the hydrophilic tip detached exposing the tip of the metal corewire.No part of the device detached inside the patient.The procedure was completed with a new jagwire guidewire.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.

Event Description

It was reported to boston scientific corporation that a jagwire guidewire was used during an endoscopic retrograde cholangiopancreatography procedure performed on (b)(6) 2014.According to the complainant, during the procedure, the ultratome xl was inserted through the non bsc duodenoscope for cannulation.Once the tip of the ultratome xl was inside the common bile duct, the jagwire guidewire was inserted into the ultratome xl.When the guidewire reached the ampulla, it was noticed that the hydrophilic tip detached exposing the tip of the metal corewire.No part of the device detached inside the patient.The procedure was completed with a new jagwire guidewire.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

(b)(6).(b)(4).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 1.8cm.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.It is most probable that anatomical/procedural factors could have generated the failure encountered.Based on all gathered information, the most probable root cause is "operational context." a dhr (device history record) review was performed and no deviation was found.

• 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: 4355371
• MDR Text Key: 5204753
• Report Number: 3005099803-2014-04023
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K141820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2014

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: Physician
• Device Expiration Date: 10/22/2016
• Device Model Number: M00556581
• Device Catalogue Number: 5658
• Device Lot Number: 16479630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2015
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2013
• 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 Age: 73 YR
• Patient Weight: 52