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

Model Number 931F75

Device Problems Leak/Splash (1354); Insufficient Flow or Under Infusion (2182); Failure to Infuse (2340)

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

Event Date 11/30/2018

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 lot number was not provided, therefore a device history record could not be completed.

Event Description

It was reported that a swan-ganz catheter was leaking during use, causing medication to not infuse properly in a clinically unstable cvicu patient with multiple vasopressors infusing.The blood pressure was unstable in spite of increasing doses of vasopressors when the clinician noted the dressing on the patient¿s chest was wet and on closer observation it was noted that fluid was leaking from an area on the proximal area of the catheter.The drug infusions were moved from the swan-ganz catheter to the cordis, with improvement in the patient¿s hemodynamics then noted.In order to solve the issue, the catheter was removed.As of the reporting date in jan-2019, there was no allegation of patient injury or consequence as a result of this issue, which occurred in (b)(6) 2018.Patient demographics were requested and not provided.The lot number was unknown.

Manufacturer Narrative

Our product evaluation laboratory received one model 931f75 catheter with a monoject limited volume syringe.The catheter body had two cuts at approximately 78cm proximal from the distal tip.The cuts were 0.05 inches and 0.02 inches in length, respectively.The 0.05 inch cut entered the rv pacing/infusion lumen and leakage was observed when pressurizing the lumen.The 0.02 inch cut was noted to just be surface damage.The balloon inflated clear and concentric, and remained inflated for 5 timed minutes without leakage.All other through lumens were patent without any leakage or occlusion.The customer report of "leaking" was confirmed on 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 are well described in the literature.With any hemodynamic monitoring, values can change quickly and dramatically and should correlate with the patient¿s clinical manifestations.If they do not correlate to the clinician¿s satisfaction, the catheter can be exchanged if desired.In this instance, an unknown type and amount of vasopressor was lost through a leak in the proximal area of the catheter and the lack of adequate medication caused an unstable blood pressure in the patient.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

Patient demographics were obtained from the customer.

Manufacturer Narrative

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: 8363017
• MDR Text Key: 137412280
• Report Number: 2015691-2019-00620
• 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: foreign,health professional,o
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 931F75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 68