MAUDE Adverse Event Report: ANGIO DYNAMICS INC. SMART PORT POWER INJECTABLE PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Lot Number A1923003

Patient Problems Pulmonary Embolism (1498); Dyspnea (1816); Numbness (2415); Cough (4457)

Event Date 10/26/2023

Event Type  Injury  

Event Description

(b)(6) woke up with arm numbness / tingling, went to er had positive life-threatening ct scan and labs.(b)(6) was flown to (b)(6) with saddle pulmonary embolism treated, and released (b)(6) had surgery and will have follow up appointments post surgery.On blood thinners as well.Dry cough as well, increase shortness of breath.

• Brand Name: SMART PORT POWER INJECTABLE PORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ANGIO DYNAMICS INC.
• MDR Report Key: 18205092
• MDR Text Key: 329134545
• Report Number: MW5148479
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2023

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?: No
• Device Operator: Health Professional
• Device Lot Number: A1923003
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Hospitalization; Life Threatening
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 124 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White