MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CATHETERS; CATHETER, FLOW DIRECTED

Model Number 777F8

Device Problem Break (1069)

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

Event Date 07/20/2022

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.

Event Description

As reported, while removing this swan ganz catheter, it got caught on a trialysis line (used as a dialysis line) located into the left internal jugular (ij), causing this swan ganz catheter tip to break apart.The patient was initially admitted with cardiogenic shock post cardiac arrest and was undergoing a procedure in the cardiac cath lab.Following removal of the catheter, the physician pulled back the teleflex cordis introducer and noted that the swan ganz tip was stuck in the introducer.No other troubleshooting or intervention was required.There was no allegation of patient injury.Follow up has started for the device return for evaluation.

Manufacturer Narrative

One swan ganz catheter was received by our product evaluation laboratory for a full evaluation.The report of broken catheter body was confirmed.As received, catheter body tube was completely broken off at 26 cm from the catheter tip.The cross surface of broken tube was rough.The edges of the broken section appeared to match at the break site.Thermistor and thermal filament lead wires and optical fiber were also broken at the broken catheter area.No visible damage was observed from balloon.Additionally, the lot number for this device was not supplied; therefore, the related manufacturing records were unable to be reviewed.On the other hand, the following additional information was received: used introducer size was 9 fr.As reported, while removing this swan ganz catheter, it got caught on a trialysis line (used as a dialysis line) which was co-located in the left internal jugular (ij), causing damage to this swan ganz catheter.On complete removal it was discovered by the user that a portion of the catheter had completely detached at the damaged location, approximately 26cm from the catheter tip.To troubleshoot, the user retracted the 9 fr teleflex cordis introducer and managed to recover the missing portion of the catheter which was partially lodged inside.There was no allegation or indication a device malfunction contributing to this adverse event.Investigation results suggest the root cause is related to the interaction between the two indwelling catheters.No other troubleshooting or intervention was required.As per customer opinion, there is no allegation of a device durability issue, and this event was just an accident.There was no allegation of patient injury.There is no statement in the instructions for use regarding catheter manipulation when it is co-located with other catheters in the patient's same great vessel; however, it is considered standard of practice to ensure that during catheter removal if resistance is encountered, care is taken via gentle manipulation and avoidance of excessive traction forces.Complaint histories for all reported events are reviewed through trending on a monthly basis and continue to be monitored for any unfavorable trends and documented as part of this monthly review.No corrective or preventative actions are required at this time.

• Brand Name: SWAN-GANZ CATHETERS
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; edwards lifesciences, pr; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 15259122
• MDR Text Key: 303061954
• Report Number: 2015691-2022-07409
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Male