MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IMPULSE; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	H74916391221
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with history of coronary artery disease and chest pain.While having a heart catheterization, the device was able to flush but the wire was unable to be threaded through.No known harm to patient.

• Brand Name: IMPULSE
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10331842
• Report Number: 10331842
• Device Sequence Number: 19738773
• Product Code: DQO
• UDI-Device Identifier: 08714729344834
• UDI-Public: (01)08714729344834(17)220421(10)60239135
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/15/2020
• Report Date (Section F): 07/15/2020

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 Model Number: H74916391221
• Device Lot Number: 60239135
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2020
• Patient Sequence Number: 1
• Patient Weight: 59
• Date Report Sent to FDA: 07/15/2020