MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER; CATHETER, FLOW DIRECTED

Model Number SWAN GANZ UNKNOWN

Device Problems Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Flutter (1730); Bradycardia (1751); Chest Pain (1776); Death (1802); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Myocardial Infarction (1969); Foreign Body In Patient (2687)

Event Date 08/19/2014

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.No actions will be taken at this time.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the 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, a re-exploration procedure was required to retrieve the swan-ganz catheter from the suture line.Any vessel perforation/damage may cause significant bleeding/ injury.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.

Event Description

Upon notification of an (b)(6) registry patient's expiration, a review of records indicated that during the patient's hospital stay back in (b)(6) 2014, a 7f swan-ganz catheter was retained in the suture line status post coronary artery bypass graft (cabg) and mitral valve repair on (b)(6) 2014, which required a re-exploration procedure to retrieve.The patient was admitted on (b)(6) 2014 and discharged on (b)(6) 2014.On (b)(6) 2014 the patient presented to the emergency room with complaints of retrosternal chest pain and shortness of breath.He was then transferred from that hospital to the hospital of record in this event for an st elevation myocardial infarction (stemi).Upon admission the patient underwent a cardiac catheterization and was diagnosed with triple vessel coronary artery disease, severe mitral valve regurgitation, and severe pulmonary hypertension with an ejection fraction of 30%.The patient underwent a cabg and mitral valve repair using an edwards model 5200 physio ii annuloplasty ring.It is unknown how the retained swan-ganz catheter was discovered post-operatively or at what point the patient underwent re-exploration to retrieve it; however, it is noted that the patient experienced non-specific leukocytosis "on and off throughout his stay" with no associated fever and negative blood cultures.The infectious disease specialist prescribed empirical rocephin in case of occult infection.It is not stated if the retained catheter was attributed to the patient's leukocytosis.The patient was reported to have developed significant atrial flutter and bradycardia post-operatively and a permanent pacemaker was placed on (b)(6) 2014, with one dose of vancomycin given post-procedure.The patient was also diagnosed with acute kidney injury/contrast nephropathy, then ischemic acute tubular necrosis, and noted to undergo dialysis with three times weekly dialysis ordered as on outpatient on discharge.There was no allegation in the records of patient complication or compromise related to the retained piece of swan-ganz catheter, nor is the patient's death on (b)(6) 2019 related to the above described event.The model and lot number are unknown.

Manufacturer Narrative

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

• Brand Name: SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8936263
• MDR Text Key: 160223868
• Report Number: 2015691-2019-03201
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K934742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 71 YR