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

Model Number PE074F5

Device Problems Inflation Problem (1310); Appropriate Term/Code Not Available (3191)

Patient Problems Internal Organ Perforation (1987); Cardiac Perforation (2513)

Event Date 02/06/2019

Event Type  Injury  

Manufacturer Narrative

The device evaluation is in progress.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

It was reported that the patient experienced perforation of the right ventricle during insertion of a swan ganz pacing catheter during a tavr procedure.The customer reported that the balloon seemed to inflate eccentrically.Addition information regarding the case has been requested.

Manufacturer Narrative

One bipolar pacing catheter with attached monoject 1.3 cc limited volume syringe was returned for evaluation.As received, an unknown brown material was observed from the balloon latex.The balloon inflated clear with 1.3 cc air and the balloon remained inflated for 5 minutes without leakage.No resistance was felt during injecting air.No visible damage or deterioration to the balloon latex and balloon windings was found.Eccentricity was measured 0.04" (rmax=0.23", rmin=0.19") and was found to be out of specification.Specification for eccentricity is 0.035" per procedure.No visible damage to the catheter body or returned syringe was found.The material was sent to chemistry for analysis.Ir spectrum of the unknown brownish material on the surface of the balloon showed similar absorption characteristic when compared to polydimethylsiloxane-like material (silicone).Balloon inflation test was performed using returned syringe with 1.3 cc air.Visual examination was performed under microscope at 20x magnification and with the unaided eye.Customer report of "the balloon seemed to have inflated eccentrically" 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.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.It is standard practice to inspect the catheter before use.The ifu states to flush the catheter lumens and check balloon integrity including major asymmetry and leaks.At this time, the comorbidities of the patient that may have contributed to the ventricular perforation are unknown as well as if user or procedural factors played a part.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.

Manufacturer Narrative

Additional information regarding the patient condition was obtained on 03/27/19 and the patient was reported to ¿be well¿.Patient demographic information requested but unavailable.The hospital refused to provide the detailed information.No further details can be obtained.

Manufacturer Narrative

Reference capa-20-00141.

• 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
• MDR Report Key: 8375677
• MDR Text Key: 137366070
• Report Number: 2015691-2019-00659
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• PMA/PMN Number: K813521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PE074F5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1