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

Model Number	M00556561
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	05/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a jagwire guidewire was used in the bile duct during a common bile duct stone removal procedure on (b)(6) 2022.During the procedure, it was confirmed via endoscopy that a few millimeters of the corewire tip broke while manipulating the guidewire.The tip part detached in duodenum and remained in the patient body.The procedure was completed with an endoselector guidewire.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a jagwire guidewire was used in the bile duct during a common bile duct stone removal procedure on (b)(6) 2022.During the procedure, it was confirmed via endoscopy that a few millimeters of the corewire tip broke while manipulating the guidewire.The tip part detached in duodenum and remained in the patient body.The procedure was completed with an endoselector guidewire.There were no patient complications reported as a result of this event.Additional information received on 29jun2022: based on the preliminary investigation, the corewire was not broken however its hydrophilic tip was peeled.
Additional Manufacturer Narrative
Block h6 (evaluation conclusion codes): the device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Correction: b5, h6 (device codes): h10: the returned jagwire was analyzed.The distal tip of the device was bent.As per inspection under magnification, it showed the distal tip of the device with a missing portion.However, there is no evidence of core wire fracture.Based on the condition of the returned device, engineers determined that the problem observed is possibly due to excess of manipulation against this unit.It is most likely that as part of the device manipulation during procedure an excess of force was applied to the device such as during the guidewire insertion through another device or the interaction with the scope causing the damage on the distal end.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.It is most likely that the adverse event occurred during the procedure and the device had no influence on event which led to the reported event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a jagwire guidewire was used in the bile duct during a common bile duct stone removal procedure on (b)(6) 2022.During the procedure, it was confirmed via endoscopy that a few millimeters of the corewire tip broke while manipulating the guidewire.The tip part detached in duodenum and remained in the patient body.The procedure was completed with an endoselector guidewire.There were no patient complications reported as a result of this event.The device was returned.

• 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: 14856246
• Report Number: 3005099803-2022-03490
• Device Sequence Number: 12051591
• Product Code: OCY
• UDI-Device Identifier: 08714729501374
• UDI-Public: 08714729501374
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2022

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: 02/21/2025
• Device Model Number: M00556561
• Device Catalogue Number: 5656
• Device Lot Number: 0028918730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 06/29/2022; 06/30/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 06/29/2022; 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2022
• 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 Sex: Unknown