MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION KINETIX GUIDE WIRE

Model Number H74939122010

Device Problems Fracture (1260); Tip breakage (1638)

Patient Problem No Information (3190)

Event Date 03/31/2015

Event Type  Injury  

Event Description

During cath procedure, short guide wire tip fractured off at tip of guide cath.

• Brand Name: KINETIX GUIDE WIRE
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; one boston scientific place; natick MA 01760 1537
• MDR Report Key: 5250050
• MDR Text Key: 32159411
• Report Number: 5250050
• Device Sequence Number: 1
• Product Code: DQX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H74939122010
• Device Lot Number: 17665566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/31/2015
• Device Age: NA
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 93