MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ THERMODILUTION PACEPORT CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 780F75M

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2019

Event Type  malfunction  

Manufacturer Narrative

Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.A device history record review was completed and documented that the device met all specifications upon distribution.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 standard clinical practice to inspect these devices prior to use on a patient.Any issue with the hub being broken would be observed during this inspection.The catheter can be exchanged easily for another one, causing a minor delay in treatment or monitoring.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 to the ew rep that the customer had an issue with a sv02 swan-ganz catheter.The temperature port (white port) came apart from the yellow connection of the catheter.Per the customer, it may have gotten pulled, but they said it ¿just came apart when they connected it to do cardiac outputs.¿ the customer stated ¿this was a rare occurrence.¿ the occurrence date is unknown.There was no patient harm.No further information is known, including patient demographics.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: SWAN-GANZ THERMODILUTION PACEPORT CATHETER
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8570424
• MDR Text Key: 143982089
• Report Number: 2015691-2019-01553
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• PMA/PMN Number: K803058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2020
• Device Model Number: 780F75M
• Device Lot Number: 61689544
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1