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

Model Number 774F75

Device Problem Looping (1370)

Patient Problem No Code Available (3191)

Event Date 12/23/2016

Event Type  malfunction  

Manufacturer Narrative

The device has been returned for evaluation, but the evaluation has not been completed.A supplemental report will be sent with the evaluation results.A device history record review was completed and documented that the device met all specifications upon distribution.No actions will be taken at this time.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, removal, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature.

Event Description

As reported, when this swan ganz catheter was removed a few centimeters from inside the patient to relocate it correctly, it looped and the distal part of the device did not pass in the right ventricle.Furthermore, customer did an echography and it was confirmed the device had looped.Therefore, an incision in the skin was done to remove the catheter from inside the patient as it was not possible to remove it from inside the patient by deflating the balloon.Another device was not inserted.The patient died, however it was not related to the issue with the swan ganz catheter.The catheter is available for evaluation.Patient demographics not obtained.

Manufacturer Narrative

The report of "the device had looped" was not confirmed.The catheter was returned without any loop.Visual inspection found two indentations on the catheter body at around 43cm and 108cm proximal of the distal tip.One kink on the catheter body was at 43cm proximal of the distal tip.The kink and indentations locations were corresponding to the locations of the attached introducer and contamination shield.There were wrinkles on the catheter body caused by bunched thermistor at the 8cm proximal of the distal tip, which is an indication the catheter has been stretched.There were 6 cuts on the catheter body from 5cm to 6cm proximal of the distal tip.Distal lumen had leakage through the larger cut located at 5cm proximal of the distal tip.The two cuts located at the 6cm area do not leak.The larger cut located distal of the port enters the proximal injectate lumen and the thermistor lumen.The smaller cut did not puncture the catheter body.Proximal lumen was patent and did not leak.The thermal filament cover was separated from its distal and proximal bonds.The balloon inflated clear and concentric and did not leak.The thermistor circuit and thermal filament circuit were continuous.Resistance value of thermal filament circuit was measured 36.95 ohms, which was in specification.The thermistor was submerged in a 37.0c water bath and read 37.0c on vigilance ii monitor.The eeprom data was found to be normal, both the stored data and the computed data matched.The catheter ran cco in 37.0 c water bath on vigilance ii monitor for 5 minutes with no error.Optics testing was performed and the catheter failed invitro calibration testing.Optic fiber was removed from the catheter body and was placed next to the catheter body.There were kinks on the fiber which corresponded to the wrinkle location (8cm) on the catheter body.It was confirmed that there was light leakage at the kink locations.Per the ifu: catheter looping may occur when excessive length has been inserted, which could result in kinking or knotting.If the right ventricle is not entered after advancing the catheter 15 cm beyond entry into the right atrium, the catheter may be looping, or the tip may be engaged in a neck vein with only the proximal shaft advancing into the heart.Deflate the balloon and withdraw the catheter until the 20 cm mark is visible.Re-inflate the balloon and advance the catheter.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.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.No corrective or preventative actions are required at this time.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER
• Type of Device: SWAN-GANZ CCOMBO V 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: 6432964
• MDR Text Key: 70877994
• Report Number: 2015691-2017-00778
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2017

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: 04/09/2018
• Device Model Number: 774F75
• Device Lot Number: 60378030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/02/2017
• Initial Date FDA Received: 03/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2016
• 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