MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER; CATHETER, FLOW DIRECTED

Model Number 831F75P

Device Problems Particulates (1451); Contamination /Decontamination Problem (2895); Physical Resistance/Sticking (4012)

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

Event Date 02/14/2019

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation laboratory received one model 831f75 catheter with a non-edwards contamination shield.The catheter was received in the decontamination lab without any packaging or tray.Multiple unknown silvery material were found on the catheter body at 47cm proximal from the catheter tip.The largest piece was approximately 0.05inches x 0.07inches in size, and detached from the catheter while wiping the catheter with a sanitizing wipe.The catheter body around the contaminated location appeared to be melted or damaged by heat.The catheter passed a lab sample 8.5f introducer without difficulty.All through lumens were patent without any leakage or occlusion.The balloon inflated clear and concentric, and remained inflated for more than 5 timed minutes without leakage.The unknown silvery material will be sent to chemistry for analysis and a supplemental report will be filed with the findings.A device history record review was completed and documented that the device met all specifications upon distribution.The customer report of "met resistance" was not 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 is well described in the literature.It is standard clinical practice to check all components of the device prior to use.In this case, a metal fleck was noted on the catheter body.If this piece of metal had remained on the catheter, the retained fragment could have embolized to the lungs.Due to the large surface area of the pulmonary vasculature, this is generally well tolerated, but can lead to complications such as infection or small infarction.In this case, there was no injury noted to the patient as the catheter was exchanged for a new one.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.Udi # (b)(4).

Event Description

It was reported that during a heart case in the cvor, the anesthesiologist was inserting a model 831f75p swan-ganz catheter into the sheath and met resistance at the 7cm mark.A ¿small metallic fleck¿ was noted to be ¿adhered to the catheter body.¿ the exact location of the particle was unknown to the customer, but it was ¿easy to visually identify.¿ the customer took an x-ray of the catheter and confirmed the fleck was metal.There was no patient injury and no known diagnostics or interventions were performed to confirm no additional metal pieces were in the patient.Patient demographics are unknown.It was noted that on 03/05/19, a medwatch report (mw5084117) was received.

Manufacturer Narrative

The unknown silvery material found on product evaluation was sent to chemistry for analysis.Per the chemistry evaluation, ir spectrum of the unknown silver particle found on the catheter was inconclusive, as no relevant match of the sample was found when compared to the spectrum library.Eds detected the flowing elements from the white particles: tin and chloride.The engineering evaluation will determine if the identified elements are found in the manufacturing process.A supplemental report will be provided upon completion of the investigation.

Manufacturer Narrative

An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.The manufacturing process was verified, and the solder wire used in the resistance solder process contains the component tin (chemical element symbol: sn).

Manufacturer Narrative

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

• Brand Name: SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER
• 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: 8409166
• MDR Text Key: 138932846
• Report Number: 2015691-2019-00819
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K810352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2020
• Device Model Number: 831F75P
• Device Lot Number: 61553555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1