MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN

Model Number 123F6P

Device Problem Separation Problem (4043)

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

Event Date 10/18/2022

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation lab received one model 123f6 catheter.As received, the balloon was found to be ruptured and inverted over the distal tip.After returning the balloon to its original position, the balloon edges did not appear to match up.All through lumens were patent without leakage or occlusion.No visible damage was observed from the catheter body.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.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.

Event Description

It was reported that during a heart catheter procedure, the physician inflated the balloon on a model 123f6 swan ganz catheter and proceeded to float it into position.Immediately after insertion, he looked and could not find the balloon.Upon removal of the swan, the balloon was noted to be completely gone from the tip of the catheter.The lot number for the device was unknown.The physician performed an inflation test on a second catheter and then overinflated the balloon to see if the balloon would burst, which it did.He used a third catheter to finish the left heart catheterization portion of the procedure, but did not complete the right heart catheterization.There was no patient injury, and no adverse events or changes in condition to the patient overnight.Patient demographics were provided.

• Brand Name: SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN
• Type of Device: SWAN-GANZ TRUE SIZE MONITORING
• 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: 15772487
• MDR Text Key: 305884682
• Report Number: 2015691-2022-09083
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2024
• Device Model Number: 123F6P
• Device Catalogue Number: 123F6P
• Device Lot Number: 64207111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2022
• 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
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 127 KG