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

Model Number 831F75

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 03/17/2022

Event Type  malfunction  

Event Description

It was reported that using this swan ganz catheter, the temperature was off and kept jumping up and down.A different cable and hemosphere were tried but the issue remained, so eventually the customer just used manual cardiac output (co).The catheter was removed after that.There was no patient injury.The product is available for return.

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation results when received.

Manufacturer Narrative

One 831f75 catheter with monoject limited volume syringe and non-edwards contamination shield was returned for examination.The reported issue of temperature was off and kept jumping up and down was unable to be confirmed.The catheter was connected to the hemosphere monitor and the thermistor was found to have a full open condition.The thermistor connector was opened.The thermistor lead wires were found broken in the connector and the service loops were absent.Lead wires in the catheter body, from 3cm to 46cm proximal from catheter tip, were bunched.The catheter body had 3 kinks, at about 55cm, 57.5cm and 58cm, proximal from catheter tip.The location of the kinks lined with the location of the proximal connector of the non-edwards contamination shield.All through lumens were found to be patent and did not leak.The balloon inflated clear and concentric and did not leak.A device history record review cannot be performed since the lot number is unknown.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 part of this monthly review.Correction: due to the product being returned the model number was found to be: 831f75.

• Brand Name: SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• 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: 14022365
• MDR Text Key: 292495519
• Report Number: 2015691-2022-04864
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 831F75
• Device Catalogue Number: 831F75P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2022
• 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