MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR PRESEP CENTRAL VENOUS OXIMETRY SET; CATHETER, OXIMETER, FIBEROPTIC

Model Number X3820HS

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2016

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However the complaint could not be confirmed without the completion of the product evaluation.A supplemental report will be forthcoming with the evaluation results.

Event Description

It was reported that when passing the presep catheter, it did not progress, a new puncture was done in the subclavian with another catheter (double lumen).There was no allegation of patient injury.Device was available for evaluation.

Manufacturer Narrative

We received one triple lumen 20cm presep catheter without the packaging for examination.The reported event of "when passing this presep (cvc (jung e) it did not progress" was not confirmed.A new guidewire (lab sample 0.032") was used to pass hub to tip and tip to hub and there were no obstructions or restrictions encountered the entire length through the catheter distal lumen.Leak testing was performed on all through lumens and no leakage was observed.The catheter body was examined and there were no kinks, bend or indentations observed.In-vitro calibration was performed and the catheter was found to also pass in-vitro calibration.The reported event was not confirmed.Although the cause of the complaint could not be determined, there was no indication of a manufacturing defect noted during the analysis.No actions will be taken at this time.A review of the manufacturing records indicated that the product met specifications upon release.

• Brand Name: PRESEP CENTRAL VENOUS OXIMETRY SET
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• 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: brian hurd-servin ; 1 edwards way; irvine, CA 92614 ; 9492506423
• MDR Report Key: 5800441
• MDR Text Key: 49757445
• Report Number: 2015691-2016-02254
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K053609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2017
• Device Model Number: X3820HS
• Device Lot Number: 60185290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2016
• Initial Date FDA Received: 07/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2015
• 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