MAUDE Adverse Event Report: BTG YOKNEAM ICESEED NEEDLE; UNIT, CRYOSURGICAL, ACCESSORIES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Fatigue (1849); Pneumothorax (2012); Dizziness (2194); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/08/2023

Event Type  Injury  

Manufacturer Narrative

H6: impact code for decreased appetite not available.

Event Description

It was reported that a left pneumothorax occurred.The event was reported as part of an investigator initiated study (iis), cryoablation to improve response to pembrolizumab in metastatic bladder cancer.A cryoablation needle was selected for use in a cryoablation procedure to treat metastatic urothelial carcinoma.The cryoablation was performed on a left upper lobe nodule in the lung.The patient's final dose of their first cycle of pembrolizumab was on (b)(6) 2023.On (b)(6) 2023, the patient began reporting dyspnea on exertion.Their home spo2 was typically in the 90s, occasionally as high as 97%.The patient also reported increased fatigue and decreased appetite, as well as occasional mild lightheadedness.When a chest x-ray was performed, a small to moderate left pneumothorax was observed, which was likely delayed following the recent procedure.Thoracic was consulted, which advised the patient to go to the emergency department.In the emergency department, a pigtail catheter was placed to provide negative pressure to fully re-inflate the lung.The pigtail catheter was placed on (b)(6) 2023 on -20 suction.A repeat chest x-ray the next day, (b)(6) 2023, showed no pneumothorax.The patient was breathing comfortably on room air, and physical exam also showed the lungs were clear, abdomen was soft, and there was no peripheral edema.The next morning, on (b)(6) 2023, the catheter was placed on water seal and then placed to clamp position.A new trace pneumothorax was present on the (b)(6) 2023 chest x-ray.The treatment was repeated, which then resolved the pneumothorax.The patient was discharged, and the plan was for them to follow up with outpatient oncology.

• Brand Name: ICESEED NEEDLE
• Type of Device: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG YOKNEAM; tavor bldg 1, industrial park; po box 224; yokneam 20692 03; IS 2069203
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; tavor building number 1; yokneam 20692 03; IS 2069203
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17877473
• MDR Text Key: 324999760
• Report Number: 2124215-2023-50102
• Device Sequence Number: 1
• Product Code: GEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Female