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 12/01/2015

Event Type  malfunction  

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

Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report# 3005099803-2015-03598, 3005099803-2015-03600 and 3005099803-2015-03599 for the other associated device information.It was reported to boston scientific corporation that three jagwire guidewires were used during an endoscopic retrograde cholangiopancreatography procedure performed on (b)(6) 2015.According to the complainant, during preparation, the hydrophilic tip became detached, exposing the tip of the metal corewire.Two more jagwire guidewires were prepared; however, the hydrophilic tips also detached, exposing the tips of the metal core wires.The procedure was completed with a fourth 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

A visual evaluation of the returned guidewire revealed that the tip of the guidewire was peeled, exposing the corewire by approximately 3.6cm.The tip of the metal corewire was not exposed.Evidence of adhesive remnants were found which indicate that the pebax tip was correctly adhered during the manufacturing process.There was no evidence of corewire fracture.The complaint is not consistent with the returned guidewire since the tip was peeled and the tip of the metal corewire was not exposed.Based on all gathered information, the investigation fails to determine a definite root cause.There is an investigation in place to address distal tip related issues.A dhr (device history record) review was performed and no deviation was found.A labeling review was performed and there is no evidence that the device was not used in accordance with the labeling.

Event Description

Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report# 3005099803-2015-03598, 3005099803-2015-03600 and 3005099803-2015-03599 for the other associated device information.It was reported to boston scientific corporation that three jagwire guidewires were used during an endoscopic retrograde cholangiopancreatography procedure performed on (b)(6) 2015.According to the complainant, during preparation, the hydrophilic tip became detached, exposing the tip of the metal corewire.Two more jagwire guidewires were prepared; however, the hydrophilic tips also detached, exposing the tips of the metal core wires.The procedure was completed with a fourth 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.

• 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: 5317349
• MDR Text Key: 34078591
• Report Number: 3005099803-2015-03599
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• PMA/PMN Number: K141820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2015

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: 06/11/2018
• Device Model Number: M00556581
• Device Catalogue Number: 5658
• Device Lot Number: 18091713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2015
• 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
• Patient Age: 67 YR
• Patient Weight: 70