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

Model Number	H74916391411
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	04/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Middle-aged male with new onset of chest pain.Procedure: right and left heart cath.Device had a pin hole inside of the catheter by the port end.Device removed without known harm to the patient.Manufacturer response for catheter, intravascular, diagnostic, impulse¿ (per site reporter): will obtain.

• 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: 14134874
• Report Number: 14134874
• Device Sequence Number: 11835450
• Product Code: DQO
• UDI-Device Identifier: 08714729214342
• UDI-Public: (01)08714729214342(17)240214(10)60346974
• 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): 04/08/2022
• Report Date (Section F): 04/08/2022

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: H74916391411
• Device Lot Number: 60346974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 122 KG
• Date Report Sent to FDA: 04/08/2022