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

Model Number	M00556581
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a jagwire was used in the common bile duct during an ercp (endoscopic retrograde cholangio pancreatography) procedure on (b)(6) 2021.During preparation, the nurse noticed that the guidewire tip was peeled.The procedure was completed with a new jagwire guidewire.There were no patient complications reported due to 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: corewire was broken.
Additional Manufacturer Narrative
(physician's phone number): the physician second phone number is: (b)(6).Problem code: (b)(4).A jagwire guidewire was returned.The device returned fractured in two pieces, the distal tip of the device was inspected under magnification and did not showed any failure on its surface.The reported event of guidewire tip peeled was not confirmed.During the product analysis, it was found that the guidewire corewire was detached or fractured on the mid section.Based on the condition of the returned device, engineers determined that the problem observed was caused when the device surface had interaction with other medical devices that may have caused this damage during the procedure or the physician cut the guidewire in order to discard it.The evidence is the signature of the cut surface that has all the characteristics and similar shape related to a mechanical cut.This problem will be classified as cause not established since the investigation findings do not lead to a clear conclusion about the cause of the analyzed adverse condition.The customer confirmed that the correct device was returned.According to the physician, the guidewire was not mechanically cut by another device.The team noticed that something is wrong, they put it aside and took different jagwire.Boston scientific has determined the most probable cause of this complaint is no problem detected since the investigation clearly shows there is no damage or malfunction related to the reported allegation.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: JAGWIRE
• Common Device Name: 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: 13453718
• Report Number: 3005099803-2022-00521
• Device Sequence Number: 5786041
• Product Code: OCY
• UDI-Device Identifier: 08714729339151
• UDI-Public: 08714729339151
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K141820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/20/2023
• Device Model Number: M00556581
• Device Catalogue Number: 5658
• Device Lot Number: 0025892430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female