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

Model Number 00884450004500

Device Problems Fracture (1260); Material Separation (1562)

Patient Problems Cardiac Arrest (1762); Foreign Body In Patient (2687)

Event Date 05/02/2021

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event 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.

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®
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11849561
• MDR Text Key: 251468352
• Report Number: 3011642792-2021-00006
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450004500
• UDI-Public: 00884450004500
• Combination Product (y/n): N
• PMA/PMN Number: K943739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention