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

Model Number H74916391411

Device Problem Material Puncture/Hole (1504)

Patient Problem Chest Pain (1776)

Event Date 04/07/2022

Event Type  malfunction  

Event 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¿
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 14134874
• MDR Text Key: 289437953
• Report Number: 14134874
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729214342
• UDI-Public: (01)08714729214342(17)240214(10)60346974
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 04/08/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14965 DA
• Patient Sex: Male
• Patient Weight: 122 KG