MAUDE Adverse Event Report: SWAN-GANZ CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number SWAN GANZ UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Pulmonary Embolism (1498); Rupture (2208); Cardiac Perforation (2513); No Code Available (3191)

Event Date 06/09/2016

Event Type  Injury  

Event Description

It was reported in a journal article that a (b)(6) year old female patient with acute decompensated heart failure, severe pulmonary hypertension, and atrial fibrillation on anticoagulation had a pulmonary artery catheter inserted for hemodynamic monitoring.Subsequently, the patient developed acute hemoptysis and damped pulmonary artery pressure waveforms during inflation of the catheter tip balloon.The possibility of pulmonary artery rupture was immediately recognized and confirmed with ct angiogram of the chest.Emergent interventional radiology guided coil embolization of pulmonary artery rupture and pseudoaneurysm was successful.The patients hospital stay was unremarkable and she was discharged home with no re-bleeding, confirmed by repeat ct scan of chest.

Manufacturer Narrative

This event is from a journal article that is 2 years old and the product will not be returned.The device was not returned for evaluation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.Lot number was not provided; therefore review of the manufacturing records could not be completed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature.Vessel perforation/damage may occur as a result of suturing the pulmonary artery catheter into a surrounding structure.In this case, the patient¿s hospital stay was unremarkable, and she was discharged home with no re-bleeding, confirmed by repeat ct scan of chest.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.Please note the initial medwatch was sent before all information was entered.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10106041
• MDR Text Key: 193306301
• Report Number: 2015691-2020-12026
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K934742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SWAN GANZ UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention