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	12/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.A 300cm journey guide wire was advanced within the left anterior tibial artery.It was observed that the tip of the journey wire detached within the left anterior tibial artery.The detached tip was successfully retrieved via a retrieval device, once the detached tip was within the sheath the physician used a body wire next to the retrieval device and inflated a 6mm balloon inside the sheath to trap it inside the sheath and everything was removed together.The procedure was completed with balloon angioplasty.No patient complications were reported and the patient is fine.
Event or Problem Description
It was reported that tip detachment occurred.A 300cm journey guide wire was advanced within the left anterior tibial artery.It was observed that the tip of the journey wire detached within the left anterior tibial artery.The detached tip was successfully retrieved via a retrieval device, once the detached tip was within the sheath the physician used a body wire next to the retrieval device and inflated a 6mm balloon inside the sheath to trap it inside the sheath and everything was removed together.The procedure was completed with balloon angioplasty.No patient complications were reported and the patient is fine.
Additional Manufacturer Narrative
Device evaluation by manufacturer: 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 38cm from the tip.The tip was not returned for analysis.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: 8210183
• Report Number: 2134265-2018-64740
• Device Sequence Number: 19259951
• Product Code: DQX
• UDI-Device Identifier: 08714729789840
• UDI-Public: 08714729789840
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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,Followup
• Report Date (Section B): 02/12/2019

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: 03/18/2020
• Device Model Number: 39700
• Device Catalogue Number: 39700
• Device Lot Number: 0022779473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 02/12/2019
• 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