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

Model Number	00884450002575
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A piece of an angiographic catheter broke with a piece remaining in patient during an angiogram.The procedure was then converted to a cutdown approach to attempt to retrieve this part of the device.

• Brand Name: PERFORMA®
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 12202275
• Report Number: 12202275
• Device Sequence Number: 1377331
• Product Code: DQO
• UDI-Device Identifier: 00884450002575
• UDI-Public: (01)00884450002575
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 07/06/2021
• Report Date (Section F): 07/06/2021

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: 00884450002575
• Device Catalogue Number: 7673-20M100SH
• Device Lot Number: E2061856
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Weight: 68
• Date Report Sent to FDA: 07/06/2021