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

Model Number	H74916599220
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of atrial fibrillation, coronary artery disease and hypertension.When having a heart cath, the catheter was removed from packaged and noted to be kinked when loaded onto the j wire.Not used on the 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: 10815802
• Report Number: 10815802
• Device Sequence Number: 4089634
• Product Code: DQO
• UDI-Device Identifier: 08714729304715
• UDI-Public: (01)08714729304715(17)220821(10)60254152
• 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): 11/04/2020
• Report Date (Section F): 11/04/2020

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: H74916599220
• Device Lot Number: 60254152
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2020
• Patient Sequence Number: 1
• Patient Weight: 118
• Date Report Sent to FDA: 11/04/2020