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

Model Number PE075F5

Device Problems Break (1069); Material Separation (1562)

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

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

No product was returned for evaluation; the device was discarded by the dealer.Without the return of the product, it is not possible to determine if damages or defects existed on the product.A device history record review was completed and documented that device met all specifications upon distribution.No actions will be taken at this time.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 unknown if user or procedural factors may have contributed to the event.A broken/separated pa catheter has the potential to embolize in the patient.In this case, the patient pulled on the catheter until the device broke.A broken catheter has the potential to embolize and therefore the risk to patient is not considered remote.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 swan ganz pacing catheter broke when the patient pulled the catheter during use.The catheter was broken at 80 cm from the distal end.When the catheter was extracted from the patient it was confirmed that the catheter was completely separated.The customer commented that no missing component remained in the patient.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL 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: 10407940
• MDR Text Key: 204165727
• Report Number: 2015691-2020-13129
• 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
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2021
• Device Model Number: PE075F5
• Device Lot Number: 62620680
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1