MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

Model Number PE074F5

Device Problem Detachment Of Device Component (1104)

Patient Problems Dementia (1808); Cardiac Tamponade (2226)

Event Date 12/21/2016

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.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.

Event Description

Patient had a pacing catheter placed through a jugular vein.Three days later the patient, who suffered from dementia, pulled out the catheter.The tip of the catheter was found on the floor, separated from the body of the catheter.A ct was performed to assure that no fragments of the catheter were retained in the patient, which they were not.At that time a small pericardial effusion was observed.Three days later an increase in the pericardial effusion was observed.¿damage to other organ(s) appeared¿ as well.(no further information available.) the patient was diagnosed with cardiac tamponade and pericardial puncture was performed.Patient continues ¿under treatment¿.

Manufacturer Narrative

One bipolar pacing catheter with attached monoject 1.3 cc limited volume syringe was returned for evaluation.Introducer was attached to the catheter body between 29 cm and 41 cm proximal from the catheter tip.Visual examination found that the catheter tip and the distal leadwire were completely broken off.Visual examination also found that the balloon was ruptured around the circumference at the position near the catheter tip breakage.The ruptured edges of the balloon latex appeared to have the same shape and matched up with no missing latex.Proximal electrode was found to be slipped to the distal side.Continuity testing was performed on the proximal circuit and there were no open, intermittent, or short conditions observed.Continuity testing also confirmed no open, intermittent, or short condition from the distal circuit between broken section and distal electrode connector pin.No visible damage to the balloon windings or returned syringe was observed.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.Customer report of broken catheter tip 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 BIPOLAR PACING CATHETER FOR SVC INSERTION
• Type of Device: PACING 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 PR 00610
• Manufacturer Contact: lynn selawski ; one edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 6256581
• MDR Text Key: 64947405
• Report Number: 2015691-2017-00120
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K813521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PE074F5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2017
• 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 Age: 87 YR
• Patient Weight: 46