MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS; CATHETER, FLOW DIRECTED

Model Number C146F7

Device Problems Deflation Problem (1149); Leak/Splash (1354); Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2019

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product, a supplemental report will be sent with the investigation results.A device history record review was completed and documented that the device met all specifications upon distribution.(b)(4).

Event Description

It was reported that the balloon on a non-synthetic swan-ganz catheter ruptured during use in a patient.Prior to use, the catheter was hooked up to pressure cables, all the ports were flushed, and the balloon was tested without issue.The anesthesiologist then inserted the catheter into the patient.When the waveform changed to a high pressure, he attempted to passively deflate the balloon but was unable to do so.The physician removed the catheter from the patient and the balloon was deflated; however, upon re-testing the balloon, it was discovered to have a leak in it.The suspect catheter was disconnected and another non-synthetic swan-ganz catheter was inserted.The patient was reported to be "ok" at the time of reporting, which was within 24 hours of the event.Patient demographics were requested and not provided.

Manufacturer Narrative

Our product evaluation laboratory received one model c146f7 catheter.Balloon leakage was observed from a pin hole near the center of the balloon.No visible damage was observed from the catheter body.The inflation lumen was patent without occlusion.All through lumens were patent without any leakage or occlusion.The customer report of "leak" was confirmed on evaluation; however, the customer report of a deflation issue was not confirmed during evaluation.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.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 standard 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.Balloon deflation difficulty can result in an occlusion of blood flow and possible distal ischemia.It is unknown whether user or procedural factors contributed to the stated 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.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8437453
• MDR Text Key: 139564234
• Report Number: 2015691-2019-00947
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K001063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2020
• Device Model Number: C146F7
• Device Catalogue Number: C146F7
• Device Lot Number: 61397494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1