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

Model Number PE074F5

Device Problems Deflation Problem (1149); Pacing Problem (1439)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/25/2019

Event Type  malfunction  

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 is in-progress.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 common clinical practice to check balloon integrity by inflating it to the recommended volume in order to detect any asymmetry, leakage condition or deflation issue before use of the catheter.In this event, there were no patient complications noted.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

It was reported that the balloon on the swan ganz pacing catheter was unable to deflate during use.The inflation syringe was removed from the gate valve.The customer cut the catheter body and the balloon deflated.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One bipolar pacing catheter with detached monoject 1.3 cc limited volume syringe was returned for evaluation.As received, the extension tube of the balloon inflation lumen was completely broken off at 11 cm from the proximal end of the y-adapter.A lab stylet wire was inserted from the gate valve to the broken section and from the broken section to the catheter tip and it was confirmed that the balloon inflation lumen was patent and no occlusion was found.Balloon inflation and deflation tests were performed by using a lab tuohy borst connector.Balloon inflated clear, concentric and remained inflated for 5 minutes without leakage.No resistance was felt when air was injected into balloon inflation lumen.The balloon deflated within 1 second without the syringe.The specification for balloon deflation without a syringe attached is 4 seconds.Catheter tip was found to be slightly bent.No other visible damage or abnormality to the balloon, windings, catheter body, gate valve or returned syringe was observed.Visual examination was performed under microscope at 20x magnification and with the unaided eye.A device history record review was completed and documented that device met all specifications upon distribution.Customer report of "it was unable to deflate the balloon" was not confirmed during evaluation.Could not be confirmed during the analysis, as the device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.

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: 8531926
• MDR Text Key: 142949659
• Report Number: 2015691-2019-01382
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PE074F5
• Device Lot Number: 61470957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1