AXIOM SILICONE THORACIC CATHETER 28 FRENCH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-22 for AXIOM SILICONE THORACIC CATHETER 28 FRENCH manufactured by Axiom Medical, Inc..

Event Text Entries

[118153518] Provider reviewed the pt's radiation treatment plan and planning ct on tuesday, (b)(6), noticing what appeared to be a segment of a chest tube at the apex of the left lung. Two chest tubes were placed and these were seen on post-surgical chest x-rays dated (b)(6) 2017. The pt was discharged on (b)(6) 2017. Another chest x-ray was performed on (b)(6) 2017, prior to a f/u appt with a provider. The report narrative describes a 16 cm tube in the "right upper lung field" (this is incorrect and should be "left upper lung field") while the impression states "appearance of a retained 16 cm chest tube fragment at the left upper anterior pleural space. " pt was not having any problems related to this. At time of surgery, decision was made on surgeon to leave chest tube fragment in lung for safety of pt as removing it could cause more harm. Pt with new diagnosis of left upper lug adenocarcinoma admitted to hosp for thoracotomy on (b)(6) 2017. Procedure was aborted due to size of tumor and the fact it adhered to the lung requiring a lobectomy for full removal (which the pt wouldn't tolerate).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5079347
MDR Report Key7809474
Date Received2018-08-22
Date of Report2018-08-21
Date of Event2017-11-19
Date Added to Maude2018-08-23
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameAXIOM SILICONE THORACIC CATHETER 28 FRENCH
Generic NameCATHETER, VENTRICULAR, GENERAL AND PLASTIC SURGERY
Product CodeGBS
Date Received2018-08-22
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerAXIOM MEDICAL, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.