MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCO/VIPTHERMODILUTION CATHETER WITH AMC THROMBOSHIELD; CATHETER, CONTINUOUS FLUSH

Model Number 139HF75P

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2015

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.A review of the manufacturing records indicated that the product met specifications upon release.

Event Description

It was reported that when testing the balloon, it did not deflate.The syringe was not attached.The customer tried with two more catheters without success.There was no allegation of patient injury.This case occurred in three different catheters.

Manufacturer Narrative

We received one 139f75 catheter with an attached monoject 3ml syringe with 1.5 ml limited volume for examination.The balloon inflated clear, concentric and remained inflated for 5 minutes without leakage.No resistance was felt during injection of air.No visible damage or deterioration was found from the balloon latex and balloon bond sites.The balloon deflated in 2 seconds without the syringe attached.The balloon would not fully deflate with the returned syringe attached.Per the ifu, ¿passively deflate the balloon by removing the syringe from the gate valve¿.All through lumens were patent without any leakage or occlusion.No visible damage was observed from the catheter body or returned syringe.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.

• Brand Name: SWAN-GANZ CCO/VIPTHERMODILUTION CATHETER WITH AMC THROMBOSHIELD
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5269658
• MDR Text Key: 32743448
• Report Number: 2015691-2015-03295
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K924661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2017
• Device Model Number: 139HF75P
• Device Lot Number: 60115037
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2015
• 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