MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCO/VIPTHERMODILUTION CATHETER; CATHETER, CONTINUOUS FLUSH

Model Number 139F75

Device Problems Unable to Obtain Readings (1516); Material Rupture (1546); Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2019

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation laboratory received one model 139f75 swan-ganz catheter with a contamination shield, a 1.5cc monoject syringe, and two single dpts.The balloon was found to be ruptured.The rupture edges did not appear to match up.All through lumens were patent without any leakage or occlusion.No other visible damage or abnormality was observed from the catheter body, syringe and dpts.A device history record review was completed and documented that the device met all specifications upon distribution.The customer report of a balloon issue was confirmed on evaluation.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 standard practice to check balloon integrity by inflating it to the recommended volume in order to detect any asymmetry or leakage condition before use of the catheter.When there is separation of the balloon or fragments from the pulmonary artery catheter, the retained fragment will embolize to the lungs.Due to the large surface area of the pulmonary vasculature, this is generally well tolerated, but can lead to complications such as infection or small infarction.Pulmonary complications may result from improper inflation technique.To avoid damage to the pulmonary artery and possible balloon rupture, the balloon should not be inflated above the recommended volume.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 on (b)(6) 2019, no measurements could be performed with a swan-ganz catheter.The device had worked properly prior to placement on (b)(6) 2019.The suspect catheter was removed and the customer observed the balloon was perforated.A new swan-ganz catheter was placed and the issue was solved.There was no allegation of patient injury.Patient demographics were requested and not provided.The hospital had originally reported the product to have been lost; however, it was eventually located and returned.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ CCO/VIPTHERMODILUTION CATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8702377
• MDR Text Key: 148555334
• Report Number: 2015691-2019-02178
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• PMA/PMN Number: K924661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2020
• Device Model Number: 139F75
• Device Catalogue Number: 139F75
• Device Lot Number: 61735865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1