MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number M00556581

Device Problems Break (1069); Peeled/Delaminated (1454); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual examination of the returned device revealed that the guidewire the pebax was peeled at the distal tip exposing the corewire.The corewire at the distal tip was broken.Additionally, the guidewire was kinked 150 cm from the proximal tip.It is likely that the failure modes observed could have been caused due to interaction with other devices used in the same procedure.Also, handling/manipulation of the device, the amount of force applied and procedural factors involved could have induced to the failures observed.Based on the information available and the analysis performed, the investigation conclusion code for the complaint will be documented as adverse event related to procedure since it is most likely that the adverse event occurred during the procedure and the device had no influence on event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed, and from the information available this device was used per the directions for use (dfu).

Event Description

It was reported to boston scientific corporation that a jagwire guidewire was used in the common bile duct (cbd) during an ercp (endoscopic retrograde cholangio-pancreatography) procedure performed on (b)(6) 2020.According to the complainant, during procedure, when guidewire was advance into the common bile duct, there was resistance.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.This event has been deemed a reportable event based on the investigation results: fractured corewire.

• Brand Name: JAGWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10393303
• MDR Text Key: 203164180
• Report Number: 3005099803-2020-03279
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 08714729339151
• UDI-Public: 08714729339151
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 08/11/2020

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: 11/08/2022
• Device Model Number: M00556581
• Device Catalogue Number: 5658
• Device Lot Number: 0024742082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2019
• 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: 58 YR
• Patient Weight: 78