MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HYDRA JAGWIRE; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	M00556061
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf patient code e2114 captures the reportable event of patient's perforation.Imdrf device code a0401 captures the reportable event of corewire break.
Event or Problem Description
It was reported to boston scientific corporation that a hydra jagwire was used during a rendevouz endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the hydra jagwire looked strange under radiologic procedure.When they removed it, they realized that the curvature was missing.It was also reported that the hydra jagwire came with only one flexible tip.The physician noticed it under the radiologic vision and the patient was perforated.The procedure was completed with a second hydra jagwire.No further information regarding this event has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: imdrf patient code e2114 captures the reportable event of patient's perforation.Imdrf device code a0401 captures the reportable event of corewire break.Block h11: the returned hydra jagwire was analyze.During visual, microscope and tactile inspection there were no any visible problems noted, and the core wire was not broken.The customer provided two pictures, one showed a whatsapp chat and the other showed the device inside its pouch, but the reported problem was not observed.With all available information, boston scientific concludes the reported event of core wire break was not confirmed.The device did not have any visual damages.The device was submitted to a visual, microscope and tactile inspection and did not show evidence of the alleged problem or any defect that could have contributed to the event reported.Therefore, the most probable root cause is no problem detected.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a hydra jagwire was used during a rendevouz endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the hydra jagwire looked strange under radiologic procedure.When they removed it, they realized that the curvature was missing.It was also reported that the hydra jagwire came with only one flexible tip.The physician noticed it under the radiologic vision and the patient was perforated.The procedure was completed with a second hydra jagwire.No further information regarding this event has been obtained despite good faith efforts.

• Brand Name: HYDRA JAGWIRE
• Common Device Name: STYLET FOR CATHETER, GASTRO-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: 18881836
• Report Number: 3005099803-2024-00964
• Device Sequence Number: 7838764
• Product Code: EZB
• UDI-Device Identifier: 08714729648499
• UDI-Public: 08714729648499
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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: 10/23/2025
• Device Model Number: M00556061
• Device Catalogue Number: 5606
• Device Lot Number: 0030409620
• 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: 02/12/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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: 37 YR
• Patient Sex: Female