MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CATHETERS; CATHETER, FLOW DIRECTED

Model Number 774F75

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

Patient Problem Anaphylactic Shock (1703)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

The complaint affected product was not returned for evaluation; therefore, a product non-conformance or device failure could not be confirmed.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.No corrective actions will be taken at this time.The instructions for use of the product contains the following caution statement: "caution: this product contains natural rubber latex which may cause allergic reactions." also, in the "other complications" section include a statement related to the allergic reactions."other complications- other complications include right bundle branch block, complete heart block, tricuspid and pulmonic valve damage, thrombocytopenia, pneumothorax, thrombophlebitis, nitroglycerin absorption, and thrombosis.In addition, allergic reactions to latex have been reported.Physicians should identify latex sensitive patients and be prepared to treat allergic reactions promptly." the complaint unit affected lot and manufacturing date were not provided; therefore review of the manufacturing records could not be completed.Complaints incidence will continue to be monitored, and applicable actions will be taken as required.

Event Description

It was reported as per article, (b)(6) is a (b)(6) year old man who was admitted for aortic arch and aortic valve surgery.Anesthesia was induced using appropriate doses of lidocaine, midazolam, propofol, rocuronium, sufentanil, ketamine, and cefazolin.He was also exposed to chlorhexidine for skin preparation prior to arterial and central venous catheter insertion.During floating of the pa catheter, there was profound hypotension with systolic of 55 mmhg, hypoxemia with oxygen saturation (spo2) in the low 70 percents, and elevated airway pressures with a documented peak airway pressures over 36 mmhg.Non-urticarial erythematous rash on the upper extremities was also noted.Treatment was undertaken with escalating intravenous epinephrine boluses and initiation of an infusion at 10mcg/min.Additionally, intravenous hydrocortisone 100mg, diphenhydramine 50mg, ranitidine 50mg, and 1 l fluid bolus were given.He responded well to treatment, and the case was aborted.(b)(6) was transferred to the icu and was discharged home the next day.A plasma tryptase level, drawn 40 minutes post anaphylaxis event, was positive at 15.8 mcg/l.At 6 hours after the event, tryptase level was 20.1 mcg/l, and a baseline level 10 days post-event was normal at 5.1 mcg/l.Based on his clinical presentation and elevated acute tryptase, (b)(6) had grade iv anaphylaxis.The laboratory investigations returned with two potential culprits to the intraoperative anaphylaxis.His latex was positive with an ige-latex value of 2.33 ku/l (normal value <0.35).Also, he had a mildly positive ige-pholcodine, which is a surrogate for neuromuscular blocking agents.On the other hand, he had a negative morphine ige test, which argues against the diagnosis of rocuronium anaphylaxis.The only exposure to latex was through the pulmonary artery catheter.The timing of the reaction favors latex being the culprit over rocuronium.(b)(6) developed severe hemodynamic instability immediately after floating the pulmonary catheter, while rocuronium was administered 45 minutes earlier.Overall, it is strongly suspected he had anaphylaxis to latex in the pulmonary catheter balloon.The patient reported to have never experienced any symptoms with latex balloons, condoms, or band-aids although his last latex exposure was decades ago.(b)(6) did not report any oral allergy to fruits.Due to the urgent nature of pathology requiring surgery, he was rebooked and underwent general anesthesia without muscle relaxation and pulmonary catheterization, leading to an uncomplicated surgery and recovery.

• Brand Name: SWAN-GANZ CATHETERS
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 12605668
• MDR Text Key: 277369508
• Report Number: 2015691-2021-05602
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K193466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 09/16/2021
• 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): Life Threatening; Other
• Patient Age: 55 YR