MAUDE Adverse Event Report: PERFORMA®; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	00884450002605
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient with enlarged aortic aneurysm was admitted for an endovascular repair.When injecting contrast through the catheter, from the performa® angiographic catheter broke apart into 2 pieces.Both pieces were removed without known harm to the patient.

• Brand Name: PERFORMA®
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 12258442
• Report Number: 12258442
• Device Sequence Number: 17329025
• Product Code: DQO
• UDI-Device Identifier: 00884450002605
• UDI-Public: (01)00884450002605(01)00884450002605(17)240301(10)E2061862
• 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): 07/22/2021
• Report Date (Section F): 07/22/2021

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: 00884450002605
• Device Catalogue Number: 7742-20M100SH
• Device Lot Number: E2061862
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/02/2021
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Weight: 104
• Date Report Sent to FDA: 07/22/2021