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

Model Number	00884450004500
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Foreign Body In Patient (2687)
Date of Event	05/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during an elective pulmonary embolism thrombectomy procedure, initiated by an interventional cardiologist, the straightener on the 5f performa cardiac pig-tail catheter was accidentally introduced into the patient's venous system.An attempt to snare the foreign body from the patient was unsuccessful.The patient coded during the procedure.Hospital protocols were activated and initiated to stabilize the patient.The patient is currently nonresponsive.A computerized tomography (ct) scan has been ordered to locate the foreign body.The medical staff believe the foreign body may have migrated near or within the patient's heart.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: PERFORMA®
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11849561
• Report Number: 3011642792-2021-00006
• Device Sequence Number: 14383732
• Product Code: DQO
• UDI-Device Identifier: 00884450004500
• UDI-Public: 00884450004500
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K943739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2023
• Device Model Number: 00884450004500
• Device Catalogue Number: 7529-23/B
• Device Lot Number: I1911739
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention