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

Model Number	M00556041
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned hydra jagwire was analyzed, and a visual evaluation noted it was returned without the dream tip, also the core wire was broken at dream tip section and the broken surface was irregular.No other problems were noted with the device.Based on the condition of the returned device, engineers determined that the reported event of difficult to advance the autotome 44 over the hydra jagwire was confirmed.Upon analysis, it was found the device was returned without the dream tip section.In addition, the core wire was broken at the dream tip and the surface was irregular.The problem found could have been caused by factors encountered during the procedure.Additionally, technique used during loading, patient anatomy or the interaction with the scope or other devices could have contributed with the reported event of difficult to advance and coating issue causing the resistance and eventually leading to core wire broken.Based on the information provided, the most probable root cause of the reported problem is adverse event related to procedure.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 hydra jagwire guidewire was used in the common bile duct during an ercp procedure on (b)(6) 2021.During the procedure, it was difficult to advance the autotome 44 over the hydra jagwire.The procedure completed with another hydra jagwire and the same autotome 44.There were no patient complications reported due to this event.This event has been deemed a reportable event based on the investigation results: corewire break.
Event or Problem Description
It was reported to boston scientific corporation that a hydra jagwire guidewire was used in the common bile duct during an ercp procedure on (b)(6) 2021.During the procedure, it was difficult to advance the autotome 44 over the hydra jagwire.The procedure completed with another hydra jagwire and the same autotome 44.There were no patient complications reported due to this event.This event has been deemed a reportable event based on the investigation results: corewire break.Please refer to block h10 for the full investigation details.
Additional Manufacturer Narrative
Block h6:(device code): problem code a0401 captures the reportable investigation results of core wire broke.The returned hydra jagwire was analyzed, and a visual evaluation noted it was returned without the dream tip, also the core wire was broken at dream tip section and the broken surface was irregular.No other problems were noted with the device.Based on the condition of the returned device, engineers determined that the reported event of difficult to advance the autotome 44 over the hydra jagwire was confirmed.Upon analysis, it was found the device was returned without the dream tip section.In addition, the core wire was broken at the dream tip and the surface was irregular.The problem found could have been caused by factors encountered during the procedure.Additionally, technique used during loading, patient anatomy or the interaction with the scope or other devices could have contributed with the reported event of difficult to advance and coating issue causing the resistance and eventually leading to core wire broken.Based on the information provided, the most probable root cause of the reported problem is adverse event related to procedure.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 instructions for use (ifu)/product label.

• 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
• MDR Report Key: 11624218
• Report Number: 3005099803-2021-01439
• Device Sequence Number: 3085963
• Product Code: EZB
• UDI-Device Identifier: 08714729648475
• UDI-Public: 08714729648475
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2021

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: 07/29/2023
• Device Model Number: M00556041
• Device Catalogue Number: 5604
• Device Lot Number: 0025786634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1