MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER WITH AMC THROMBOSHI; SWAN-GANZ CATHETER

Model Number 777HF8J

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2016

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.A device history record review was completed and documented that device met all specifications upon distribution.

Event Description

It was reported that blood was visualized near the optical module connector during use.The catheter was inserted in the cath lab before aortic valve replacement.It is unknown if blood leaked from the catheter or not so the catheter was replaced.There were no patient complications reported.

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe and 3 three-way stopcocks was returned for evaluation.A non-edwards contamination shield was located on the catheter body between 82 cm and 112 cm proximal from the catheter tip.No packaging or introducer was returned.Blood was observed from the strain relief of the optical module connector.Catheter body was tied by a suture at around 56 cm proximal from the catheter tip.The attached contamination shield was removed for evaluation.No visible damage to the catheter body, balloon, or returned syringe was observed.Leak testing was performed and all through lumens were patent without any leakage or occlusion.Balloon inflated clear and remained inflated for 5 minutes without leakage.The optical module connector housing was opened and blood was observed around the strain relief and housing bonding section.A cut down of the optical module connector extension tube was performed at 2 cm distal from the strain relief.No blood was found inside the extension tube.Leak testing was performed using a tuohy borst type fitting connected to the cut section of the optical fiber lumen extension tube and no leakage was observed.Additional examination of the catheter found that the catheter had no inter-lumen leaks, cuts or punctures that would account for the blood inside the optic connector and strain relief.No blood was observed inside the optic extension tube or any of the catheter lumens.The connector is located outside the catheter body and if the catheter does not have an inter-lumen leak and there is no catheter body damage, there should be no blood inside the optic connector.No defect was found with the catheter; therefore, the blood may have entered from an external source.Balloon inflation test was performed using returned syringe with 1.5 cc air.Visual examination was performed under microscope at magnification 20x and with the unaided eyes.The customer report of blood leakage was not confirmed.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER WITH AMC THROMBOSHI
• Type of Device: SWAN-GANZ 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: lynn selawski ; one edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5519903
• MDR Text Key: 41314265
• Report Number: 2015691-2016-00904
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040287
• 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: 03/01/2016

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: 11/12/2016
• Device Model Number: 777HF8J
• Device Lot Number: 60059208R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2016
• Initial Date FDA Received: 03/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2015
• 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