MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER WITH AMC THROMBOSHI; SWAN-GANZ CATHETER

Model Number 777HF8J

Device Problems Inflation Problem (1310); Difficult to Insert (1316); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)

Patient Problems Perforation (2001); Stenosis (2263)

Event Date 04/13/2016

Event Type  Injury  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.A device history record review was completed and documented that device met all specifications upon distribution for all three possible lot numbers.Possible lot numbers are lot 60274470: manufacturing date 01/11/2016, expiration date 07/13/2017, lot 60292044r: manufacturing date 01/28/2016, expiration date 07/27/2017 and lot 60237817r: manufacturing date "12/12/201", expiration date 06/13/2017.

Event Description

It was reported that a (b)(6) female patient experienced right ventricular perforation by a swan-ganz catheter during use.The patient had primary disease of aortic regurgitation (ar), mitral valve regurgitation (mr) and coronary stenosis.Aortic valve replacement (avr) was performed.The catheter was inserted from the jugular vein for monitoring, but was difficult to insert and could not be advanced due to tricuspid stenosis.Patient chest was opened to dilate the tricuspid valve.Then the catheter was passed through the tricuspid valve.The clinician attempted to advance the catheter to the pulmonary artery with force.Perforation of the right ventricle occurred.The degree of injury is unknown.The catheter was immediately removed and replaced.After removal, the customer inflated the balloon but it did not inflate.The patient is under postoperative management.The clinician commented that the perforation was most likely due to insertion technique and not product malfunction.

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe and three three-way stopcocks was returned for evaluation.A non-edwards contamination shield was located on the catheter body between 29 cm and 76 cm proximal from the catheter tip.No packaging or introducer was returned.Balloon was found to be ruptured at the central area of the balloon latex around the circumference.The distal side of the balloon latex was inverted to the distal side.After pulling the inverted balloon back to the original position, both ruptured edges of latex appeared to have the same shape and matched up with no missing latex.No visible damage to the catheter body or returned syringe was observed.All through lumens were patent without any leakage or occlusion.Balloon inflation test was performed using returned syringe with 1.5 cc air.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.Customer report of right ventricle perforation could not be confirmed during the evaluation; however, balloon inflation issue was confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER WITH AMC THROMBOSHI
• Type of Device: SWAN-GANZ CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco CA 00610
• Manufacturer Contact: lynn selawski ; one edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5645441
• MDR Text Key: 44896554
• Report Number: 2015691-2016-01566
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2017
• Device Model Number: 777HF8J
• Device Lot Number: 60274470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2016
• Initial Date FDA Received: 05/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2016
• 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 Age: 59 YR