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

Model Number	39700
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/02/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulty was encountered.The target lesion was located in the heavily calcified anterior tibial artery.A 300cm journey guidewire was advanced to the dorsalis pedis artery; however, the device was not able to enter the lesion.During retrieval, the wire was caught by the heavy calcification and was disconnected by 30cm from the tip.The patient was in good condition without further complications.The procedure was completed with another of the same device.Surgery was arranged and the wire was removed surgically.

• 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: 8354613
• Report Number: 2134265-2019-01415
• Device Sequence Number: 11312266
• Product Code: DQX
• UDI-Device Identifier: 08714729789840
• UDI-Public: 08714729789840
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 02/20/2019

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: 03/25/2020
• Device Model Number: 39700
• Device Catalogue Number: 39700
• Device Lot Number: 22524254
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention