MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ DOUBLE LUMEN MONITORING CATHETER; SWAN GANZ DOUBLE LUMEN CATHETER

Model Number 110F5

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2017

Event Type  malfunction  

Manufacturer Narrative

We received two - 110f5 catheters with 1 ml b-d syringes for evaluation at our product evaluation laboratory.No packaging or guidewire was returned.The report of "resistance with the 0.025" guidewire" was confirmed.Per the ifu the compatible guidewire for this catheter is 0.025".A 0.025" guidewire was passed from hub to tip and the guidewire became stuck at the catheter tip area.A measurement was taken of the catheter tip and the tip was found to be within specifications.Also per the ifu the recommended insertion technique is the seldinger technique which requires a guidewire for insertion of the catheter.The through lumen was found to be patent and did not leak.The balloon inflated clear and concentric and did not leak.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.A review of the manufacturing records indicated that the product met specifications upon release.Invasive procedures inherently involve some patient risks.Although serious complications associated with pulmonary artery catheters are relatively uncommon, the physician is advised before deciding to use the catheter to consider and weigh the potential benefits and risks associated with the use of the catheter against alternative procedures.The general risks and complications associated with indwelling catheters are well documented in the literature.It is unknown if procedural factors may have contributed to the reported event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.(b)(4).

Event Description

It was reported that when using this swan-ganz catheter, the physician encountered resistance with the 0.025 guidewire.A second catheter was used with a 0.018 guidewire and resistance was again felt while threading the guidewire.The initial insertion point was right basilic and they were able to float the catheter to the right subclavian.Back loading was attempted, but resistance was still felt, making it difficult to thread.It was necessary to switch to entry through the ij to complete the catheter placement.No complaints of patient injury.Patient demographics requested, but unavailable at this time.

• Brand Name: SWAN-GANZ DOUBLE LUMEN MONITORING CATHETER
• Type of Device: SWAN GANZ DOUBLE LUMEN 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: brian hurd-servin ; 1 edwards way; irvine, CA 92614 ; 9492506423
• MDR Report Key: 6411941
• MDR Text Key: 70184146
• Report Number: 2015691-2017-00691
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2017

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: 10/31/2018
• Device Model Number: 110F5
• Device Lot Number: 60615398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Initial Date Manufacturer Received: 02/23/2017
• Initial Date FDA Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• 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