MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ VIP CATHETER; CATHETER, FLOW DIRECTED

Model Number 834F75

Device Problems Material Fragmentation (1261); Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.Lot number was not provided; therefore review of the manufacturing records could not be completed.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.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.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.Medsun # (b)(4).

Event Description

It was reported that during use in a (b)(6) male patient, the nurse in the cardiovascular intensive care unit (cvicu) attempted to pull the swan ganz catheter at the order of the nurse practitioner.The nurse met resistance and stopped pulling the catheter, replaced the dressing, and notified the nurse practitioner as well as the physician.A chest x-ray was performed, and the patient was taken back to the or for fragment removal.The physician located the fragment at the juncture of superior vena cava and right atrium.It was reported that the fragment was removed without difficulty.The patient returned to cvicu post procedure.The device was discarded after the procedure and not available for return.The patient was released from the hospital in good condition.

Manufacturer Narrative

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

• Brand Name: SWAN-GANZ VIP CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR
• MDR Report Key: 9850640
• MDR Text Key: 195939689
• Report Number: 2015691-2020-11015
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K810352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 834F75
• Device Catalogue Number: 834F75
• 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
• Patient Age: 44 YR