MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER

Model Number 777F8

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that, during use of this 777f8 swan ganz catheter, lot 64381311, the balloon ruptured.Anesthesia tested the balloon with the syringe that comes in the packaging prior to insertion but when they inserted the swan into the patient and began to inflate the balloon it popped.They immediately removed the swan and placed a new one.There was no patient injury.Per product evaluation findings, balloon was found ruptured with edges not matching.

Manufacturer Narrative

Our product evaluation lab received one swan ganz 777f8 with monoject limited volume syringe with non edwards contamination shield inflation lumen was occluded with blood.The rupture edges did not appear to match up.All through lumens were patent without any leakage or occlusion.No visible damage or inconsistency was observed from the catheter body or syringe.Report of balloon ruptured was confirmed.An engineering evaluation has been initiated to assess for any manufacturing related processes which could be correlated to the complaint.A device history record review was completed and documented that the device met all specifications upon distribution.Complaint histories for all reported events are reviewed against trending control limits and any excursions above the control limits are assessed and documented as part of this monthly review.

Manufacturer Narrative

An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.As part of the manufacturing process the units go through an inspection process.A previous product risk assessment addresses and covers the failure of balloons with fragmentations for cco models.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER
• Type of Device: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 15916610
• MDR Text Key: 306506076
• Report Number: 2015691-2022-09673
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00690103146554
• UDI-Public: (01)00690103146554(17)240526(11)220527(10)64381311
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 64381311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1