MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN GANZ THERMODILUTION VENOUS INFUSION PORT CATHETER; CATHETER, FLOW DIRECTED

Model Number 831F75P

Device Problem Material Separation (1562)

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

Event Date 08/16/2023

Event Type  malfunction  

Manufacturer Narrative

The reported event of catheter broke was confirmed.Catheter body was broken into three parts at 51cm and 58cm of the catheter body.The surface of the breaks appeared rough and uneven.The edges at the breaks appeared to match up.Thermistor leadwires were broken at about 60cm in the catheter body.Thermistor leadwires at the break appaead to match up.Kink and indentations were observed at about 7cm from the catheter tip.The locations of the kink and indentations were aligned to the locations of the flexible sheath and the housing of the non edwards introducer respectively.No other visible abnormality was observed from the balloon or catheter.Further evaluation regarding related quality issues is under investigation.The lot number was not provided thus a device history record was not reviewed.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.

Event Description

It was reported that the last 30 cm of a swan ganz catheter, model 831f75, broke during removal from the patient.Per the clinical nurse specialist, the catheter broke off when nurse was removing catheter from the sheath.Nurse commented that there was a little resistance, but no complications ensued.The sales rep noted that the catheter was cleanly broken off into 2 pieces at around the 30 cm mark.There was no patient injury.

• Brand Name: SWAN GANZ THERMODILUTION VENOUS INFUSION PORT CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 17741408
• MDR Text Key: 323503831
• Report Number: 2015691-2023-15910
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K810352
• 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
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 831F75P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2023
• 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