MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO CATHETER; CATHETER, OXIMETER, FIBER-OPTIC

Model Number 777F8

Device Problem Material Separation (1562)

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

Event Date 08/01/2022

Event Type  malfunction  

Manufacturer Narrative

One 777f8 with monoject limited volume syringe, cal cup and non-edwards contamination shield was returned for evaluation.The customers report of the balloon not inflating was confirmed.The balloon did not inflate due to a tear, approximately 0.04 in length, at the distal end of the proximal balloon bond.The edges of latex did not appear to match at the torn location.All through lumens were patent without any leakage or occlusion.There was no other visible damage or abnormality observed from catheter body, the cal cup or syringe.A device history record review was completed and documented that device met all specifications upon distribution.An engineering evaluation was assigned to the manufacturing site for further investigation.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

It was reported that before use, when the clinician tested this 777f8 swan-ganz catheter balloon, it would not inflate.They attempted a few more times to inflate but it would not so they exchanged for a new swan- ganz catheter that worked fine.There was no harm or injury to the patient.The swan-ganz catheter was returned for evaluation and the edges of latex did not appear to match at the torn location of the balloon.

• Brand Name: SWAN-GANZ CCOMBO CATHETER
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• 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: 15524592
• MDR Text Key: 302355210
• Report Number: 2015691-2022-08186
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00690103146554
• UDI-Public: (01)00690103146554(17)240426(11)220427(10)64347129
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2022

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 Operator: Health Professional
• Device Expiration Date: 04/26/2024
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 64347129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 10/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2022
• 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