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

Model Number	39700
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wire was demolished.A 185 centimeter journey guidewire was selected for an embolization procedure in the superior mesenteric artery.The coiling procedure went smoothly.The wire was advanced at least ten times through the microcatheter.No resistance was encountered during insertion.After removing the wire, it was noted that the wire was breaking at the soldering point on the distal tip and it was not completely removed.The missing piece was then removed from the patient using aspiration and retrieval of the microcatheter and guiding catheter.The procedure was completed with a different device.The intervention was prolonged but there were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a separated journey guidewire.The guidewire shaft, bonds and the shaft were examined for any damage.The guidewire shaft was separated approximately 37.5cm from the tip.The damage that was noticed looks consistent with bend force, which may have contributed to the separated shaft.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
Event or Problem Description
It was reported that the wire was demolished.A 185 centimeter journey guidewire was selected for an embolization procedure in the superior mesenteric artery.The coiling procedure went smoothly.The wire was advanced at least ten times through the microcatheter.No resistance was encountered during insertion.After removing the wire, it was noted that the wire was breaking at the soldering point on the distal tip and it was not completely removed.The missing piece was then removed from the patient using aspiration and retrieval of the microcatheter and guiding catheter.The procedure was completed with a different device.The intervention was prolonged but there were no patient complications reported.

• 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: 8246926
• Report Number: 2134265-2019-00049
• Device Sequence Number: 1594245
• Product Code: DQX
• UDI-Device Identifier: 08714729789833
• UDI-Public: 08714729789833
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/14/2019

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: 12/21/2019
• Device Model Number: 39700
• Device Catalogue Number: 39700
• Device Lot Number: 0021783107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1