MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN GANZ CCOMBO V CCO SVO2 CEDV VIP THERMODILUTION CATHETER; CATHETER, OXIMETER, FIBER OPTIC

Model Number 777F8

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/04/2023

Event Type  malfunction  

Event Description

It was reported that the cvp extension tube was torn at the backform.It was unknown if the line was accidentally pulled.A new catheter was exchanged to resolve the issue.There were no patient injuries.

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product investigation.A supplemental report will be forthcoming with the evaluation when completed.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 a part of the monthly review.

Manufacturer Narrative

A product evaluation was completed.The reported extension tube torn at the backform was confirmed.Proximal injectate extension tube was detached from the backform.The finding was aligned to customer photos.Distal end of proximal injectate extension tube stopped within the insert.Per specification, extension tube should be inserted 0.300 plus minus 0.005 inches beyond the insert.The balloon inflated clear and concentric and remained inflated for 5minutes without leakage.All other through lumens were patent without any leakage or occlusion.No other visible damage was observed from catheter body.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.A capa was initiated to address the detached fitting from the backend due to a lack of insertion in the insert.Capa is currently in implementation phase.The most plausible root cause is related to manufacturing.Corrections to the h6 codes type of investigations, investigation findings, and investigation conclusions were made.A device history record review was completed and documented that device met all specifications upon distribution.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 a part of the monthly review.

• Brand Name: SWAN GANZ CCOMBO V CCO SVO2 CEDV VIP THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBER OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 17999434
• MDR Text Key: 326818609
• Report Number: 2015691-2023-17036
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00690103146554
• UDI-Public: (01)00690103146554(17)250329(11)230330(10)64954130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 777F8
• Device Lot Number: 64954130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2023
• 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