MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SWAN-GANZ CCOMBO V THERMODILUTION CATHETER; SWAN GANZ CATHETER

Model Number 774HF75J

Device Problems Crack (1135); Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2016

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.The lot number was not available.

Event Description

It was reported that blood back flow was observed from the optical module connector after surgery.The catheter was removed and blood was also noted in the balloon and a crack was observed near the proximal injectate port.The customer commented that it is possible that the catheter was cracked during surgery.There were no patient complications reported.

Manufacturer Narrative

One catheter with two three-way stopcocks attached was returned for evaluation.No syringe, packaging, or introducer was returned.As received, blood was observed from the optical module connector and under the balloon latex.The optical fiber extension tube was returned tied and the tied section was released for evaluation.Four punctures were found on the catheter body at 26.5 cm (<0.5mm long), 27 cm (1 mm long), 27 cm (1 mm long), and 29 cm (<0.5mm long) proximal from the catheter tip.A scratch mark (0.5 mm long) was observed at 27.5 cm proximal from the catheter tip.The 1mm long punctures were located on the opposite side of each other and these punctures entered into the proximal injectate lumen and optical fiber lumen.The distal lumen was patent without any leakage or occlusion.The balloon did not inflate due to a clotted blood occlusion.No visible damage to the balloon was found.Balloon inflation test was performed using lab 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 issue was confirmed, however, the leakage path of the balloon inflation lumen was not able be to determined due to an occlusion in the balloon inflation lumen.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.

• Brand Name: SWAN-GANZ CCOMBO V THERMODILUTION CATHETER
• Type of Device: SWAN GANZ CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; state rd indus pk 402 km1.4; anasco 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: lynn selawskii ; one edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5592329
• MDR Text Key: 44120864
• Report Number: 2015691-2016-01302
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/29/2016

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 Model Number: 774HF75J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2016
• Initial Date FDA Received: 04/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/08/2016
• 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