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

Model Number	M00556601
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(impact codes): imdrf impact code f08 is being used to capture the reportable event of hospitalization or prolonged hospitalization.
Event or Problem Description
It was reported to boston scientific corporation that a jagwire was used in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.It was reported that when the jagwire was pulled through, the corewire broke and remained inside the pancreatic duct.Reportedly, the patient stayed longer at the hospital for further observation and was sent for imaging.The procedure was not completed due to this event.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 was used in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.It was reported that when the jagwire was pulled through, the corewire broke and remained inside the pancreatic duct.Reportedly, the patient stayed longer at the hospital for further observation and was sent for imaging.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (impact codes): imdrf impact code f08 is being used to capture the reportable event of hospitalization or prolonged hospitalization.Block h10: the returned jagwire was analyzed.Visual analysis and microscopic inspection revealed that the distal tip had almost all the pebax detached, exposing the core wire.Additionally, there is no evidence of core wire being broken.No other problems with the device were noted.With all available information, boston scientific concludes the reported event of core wire break was not confirmed during the product investigation.Based on the condition of the returned device, it is probable that the problem occurred due to excess manipulation of the jagwire.This most likely happened during the procedure when excess force was applied to the device such as during the guidewire insertion through another device or the interaction with the scope, causing the coding to detach.Therefore, the most probable root cause is adverse event related to procedure.

• 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: 17029827
• Report Number: 3005099803-2023-02744
• Device Sequence Number: 7012337
• Product Code: OCY
• UDI-Device Identifier: 08714729172154
• UDI-Public: 08714729172154
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• 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
• Report Date (Section B): 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/15/2025
• Device Model Number: M00556601
• Device Catalogue Number: 5660
• Device Lot Number: 0030548602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 95 KG