MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR PRESEP CENTRAL VENOUS OXIMETRY KIT; PRESEP CATHETER

Model Number X3820SJD

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Infiltration into Tissue (1931)

Event Date 05/07/2018

Event Type  Injury  

Manufacturer Narrative

One triple lumen presep catheter was returned for evaluation.Non-edwards injection ports were attached at the hubs and suture loop and box clamp were attached on the catheter body at approximately 8.2cm to 10.2cm from the catheter tip.General evaluation was performed on the returned sample.No visible defect/damage to the suture loop, box clamp, or catheter body was observed.Suture loop and box clamp appeared to be properly attached on the catheter body and did not move or detach from the catheter body during evaluation.The customer commented that the suture wing was sutured to the patient¿s skin to fix the catheter.As received, sutures were not observed at suture wings of returned sample, however, indentation was observed from the suture wing which suggests that the suture wings had been stretched compared to lab sample.All through-lumens were found to be patent without any leakage or occlusion.Visual examinations were performed under microscope at 10x magnification.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Customer report of issue with subcutaneous infusion fluid retention could not be confirmed during the analysis.The device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.Complaint trending will be monitored to determine if additional actions are required.These catheters are typically inserted in patients who are either bradycardic or are undergoing a diagnostic procedure and need to be temporarily paced.They can also be placed emergently when a patient is experiencing hemodynamic instability.Per the ifu, after stable pacing has been confirmed, the proximal end of the catheter should be secured to the insertion site to prevent undue movement that could result in tip dislodgment and loss of capture, or catheter migration.Care should be taken not to kink the catheter body when securing it.In this complaint, it could not be determined if procedural factors or device handling may have contributed to the reported event.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.

Event Description

It was reported that subcutaneous infusion fluid retention was observed during use of a presep catheter near the jugular vein where the catheter was inserted.The catheter was used during aortic valve surgery.The catheter had been inserted 14 cm from the tip and fixed but was found to be 7 cm withdrawn after the surgery.The suture wing was sutured to the patient¿s skin to fix the catheter.The catheter was subsequently removed and another catheter was inserted from the femoral vein.The surgery was uneventful.The neck swelling was improved without treatment and the patient was recovering well.The patient is a (b)(6)-year-old male with medical history of aortic insufficiency, hypertension, prostatic cancer, hernia inguinalis, and hyperlipidemia.

• Brand Name: PRESEP CENTRAL VENOUS OXIMETRY KIT
• Type of Device: PRESEP CATHETER
• 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 7543272
• MDR Text Key: 109222739
• Report Number: 2015691-2018-01998
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K053609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: X3820SJD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 70