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

Model Number 774F75

Device Problem Material Rupture (1546)

Patient Problem No Patient Involvement (2645)

Event Date 10/24/2017

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation laboratory received one swan-ganz catheter.A rupture was found at the proximal end of the balloon.The latex edges did not seem to match at the ruptured region.All through lumens were patent without any leakage or occlusion.No other visible damage was observed from the catheter body.A device history record review was completed and documented that the device met all specifications upon distribution.The report of a balloon issue was confirmed.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.A root cause could not be confirmed.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, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature.It is common clinical practice to check balloon integrity by inflating it to the recommended volume in order to detect any asymmetry or leakage condition before use of the catheter.When there is separation of the balloon or fragments from the pulmonary artery catheter, the retained fragment will embolize to the lungs.Due to the large surface area of the pulmonary vasculature, this is generally well tolerated.Pulmonary complications may result from improper inflation technique.To avoid damage to the pulmonary artery and possible balloon rupture, the balloon should not be inflated above the recommended volume.It is unknown if user or procedural factors affected or contributed to this event.No further actions will be taken at this time.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 prior to use, while testing the balloon on the swan-ganz catheter, it was noted to have a tear.There was no allegation of any patient involvement or injury.Patient demographics were requested and not provided.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• 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: samantha eveleigh ; one edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 7209820
• MDR Text Key: 98185286
• Report Number: 2015691-2018-00230
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 10/25/2017

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: 12/07/2018
• Device Model Number: 774F75
• Device Lot Number: 60693072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Initial Date Manufacturer Received: 01/15/2018
• Initial Date FDA Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2016
• 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