MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ POLYMER BLEND TORQUE SUPPORT TRUE SIZE TD CATHETER WITH SPECIAL TIP BE; SWAN-GANZ CATHETER

Model Number TF252H7F

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2015

Event Type  malfunction  

Event Description

It was reported that the balloon did not inflate during use, although it inflated at the inflation test.The customer inflated the balloon again after removing the catheter from the patient and the balloon inflated.The catheter was replaced and the problem was solved.There were no patient complications reported.

Manufacturer Narrative

One catheter with monoject 1.5 cc limited volume syringe was returned for evaluation.Non-edwards three-way stopcocks were attached at the proximal injectate hub and at the p.A.Distal hub, respectively.Clotted blood was observed from the catheter body, balloon and three-way stopcocks.The balloon inflated but failed to maintain its inflation due to an interlumen leakage in the catheter body around the catheter tip between the balloon inflation lumen and the distal lumen.Leakage was noted from the distal lumen when the balloon was inflated.Proximal injectate lumen was patent without any leakage or occlusion.No visible damage to the balloon, catheter body or returned syringe was observed.Balloon inflation test was performed using returned syringe with 1.5 cc air.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.Customer report of balloon issue was confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.

• Brand Name: SWAN-GANZ POLYMER BLEND TORQUE SUPPORT TRUE SIZE TD CATHETER WITH SPECIAL TIP BE
• 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 ; 1 edwards way; irvine, CA 92614 ; 9492504386
• MDR Report Key: 4914336
• MDR Text Key: 6429309
• Report Number: 2015691-2015-01686
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K910204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2015

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: TF252H7F
• Device Lot Number: 60024521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2015
• Initial Date Manufacturer Received: 06/15/2015
• Initial Date FDA Received: 07/14/2015
• 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