MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JOURNEY; WIRE, GUIDE, CATHETER

Model Number	39700
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that distal tip detachment occurred.A 300 cm journey guide wire was selected for use with a microcatheter in an embolization procedure to treat a varicocele.However, it was noted that contrast could not be injected into the microcatheter as it appeared to be blocked.The tip of the journey wire was noted to be damaged.Upon using the backend of the wire to clear the microcatheter, it was noted that the tip of the wire was embedded into the catheter.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.
Event or Problem Description
It was reported that distal tip detachment occurred.A 300cm journey guide wire was selected for use with a microcatheter in an embolization procedure to treat a varicocele.However, it was noted that contrast could not be injected into the microcatheter as it appeared to be blocked.The tip of the journey wire was noted to be damaged.Upon using the backend of the wire to clear the microcatheter, it was noted that the tip of the wire was embedded into the catheter.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.It was further reported that the target location was located in the mildly tortuous gonadal vein varicocele.The detached tip became lodged in the microcatheter through the mid segment.The physician removed the detached tip from the patient by removing the microcatheter and wire.The intervention was then performed with a non bsc guidewire.

• Brand Name: JOURNEY
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8650582
• Report Number: 2134265-2019-05954
• Device Sequence Number: 16665856
• Product Code: DQX
• UDI-Device Identifier: 08714729789840
• UDI-Public: 08714729789840
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019

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: 08/07/2019
• Device Model Number: 39700
• Device Catalogue Number: 39700
• Device Lot Number: 0021281737
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1