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	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/31/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guide wire tip detachment occurred.The target lesion was located in the posterior tibial vessel.A 185cm journey guide wire was advanced to cross the lesion.However, it was noted that the tip of the wire broke off in the vessel.An attempt to snare the detached tip was done but it was unsuccessful.The detached tip was left inside the patient's body.No patient complications were reported and the patient's status was fine.The device was returned for analysis.The guidewire shaft, bonds and the shaft were examined for any damage.The guidewire shaft was separated approximately 3cm from the tip.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• 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: 7813760
• Report Number: 2134265-2018-60420
• Device Sequence Number: 11185727
• Product Code: DQX
• UDI-Device Identifier: 08714729789826
• UDI-Public: 08714729789826
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K081021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2018

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: 01/23/2020
• Device Model Number: 39700
• Device Catalogue Number: 39700
• Device Lot Number: 0021807622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/24/2018
• 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