MAUDE Adverse Event Report: ST PAUL PORT A CATH II POWER PAC; CATHETER, INTRAVASCULAR, THERAPEUTIC

Device Problem Material Separation (1562)

Patient Problems Dyspnea (1816); Foreign Body Embolism (4439)

Event Type  Injury  

Event Description

It was reported that parts of the device had broken off which migrated to the patient's lungs.Distal parts of the device were detached which subsequently led to a foreign body embolism in the pulmonary arteries.According to the radiological report, it is stated that the length of the catheter material in the lower lobe on the right is mediobasally 2.3 cm, posterobasally 2.5 cm and left 1.2 cm.As a result of this, parts are still embedded in the lung wings of the patient, which cannot be removed due to their location and lead to the fact that the right lung wing experiences no ventilation at all, causing shortness of breath and constantly gasping for air.

• Brand Name: PORT A CATH II POWER PAC
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14959458
• MDR Text Key: 295518241
• Report Number: 3012307300-2022-13143
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K093414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/09/2022
• Initial Date FDA Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1