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

Model Number 777F8

Device Problem Knotted (1340)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2017

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation laboratory received one swan ganz catheter with monoject limited syringe.Report of "a knot in the catheter body" was confirmed.Visual examination found the catheter looped and a knot on the catheter body 4cm proximal of the distal tip.Per the ifu, "if a right ventricular pressure tracing is still observed after advancing the catheter several centimeters beyond the point where the initial right ventricular pressure tracing was observed, the catheter may be looping in the right ventricle which can result in kinking or knotting of the catheter", and "catheter looping may occur when excessive length has been inserted, which could result in kinking or knotting." the catheter body had damage from approximately 2cm to 4cm proximal of the distal tip and the thermal filament cover at the proximal end of the distal bond was damaged.The thermistor wire appeared bunched under the body just proximal of the knot.There was a cut on the catheter body surface just proximal of the thermistor bead.The catheter failed in-vitro calibration.Light leakage was found at the damaged location and at 5cm proximal of the distal tip."check thermistor connection" error message was displayed on the vigilance ii monitor when the thermistor was connected to the monitor.The thermistor circuit was in an open condition.Cut down and continuity test confirmed open condition close to the thermistor bead location.The thermal filament circuit was continuous.There were no open or intermittent conditions.The eeprom data was found to be normal, both the stored data and the computed data matched.Resistance value of thermal filament circuit was measured at 36.92 ohms which was within specifications.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.All through lumens were patent without any leakage or occlusion.A device history record review was completed and documented that the device met all specifications upon distribution.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to perform the procedure, to consider the potential benefits in relation to the possible complications.In this case, the catheter body knotted, which required a cut-down procedure and a second insertion site.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

As reported, this swan-ganz catheter could not be positioned into the pulmonary artery, when the customer was trying to remove the swan-ganz it could not be done.By echo it was detected that there was a knot in the catheter body.Finally, the surgeon did a small incision where the introducer was placed in order to extract both the introducer and the knotted catheter.Then, a new puncture in the left side of the body was done in order to place a new introducer and catheter to continue with the procedure.The intervention could be performed and it passed without any further issues.The device was available for evaluation.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER
• Type of Device: SWAN GANZ THERMODILUTION 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: 6601329
• MDR Text Key: 76299192
• Report Number: 2015691-2017-01532
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2019
• Device Model Number: 777F8
• Device Lot Number: 60757547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Date Manufacturer Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2017
• 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
• Patient Age: 40 YR