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

Model Number 931F75

Device Problems Pacing Problem (1439); Particulates (1451); Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/28/2019

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.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.

Event Description

It was reported that a model 931f75 swan-ganz catheter had been placed with difficulty during a cabg procedure, as well as, some sort of additional trouble was experienced during the case.The exact type of ¿trouble¿ is being clarified with the physician.Post-operatively, the nurses were unable to obtain a waveform.The nurse manager is not sure if central venous pressure (cvp) waveform was noted and is following up with the bedside nurse.She states that they changed out the pressure cable but does not believe that they changed out the transducer.They did reposition the catheter but to no avail of obtaining a waveform.The swan-ganz catheter was subsequently removed due to the lack of a waveform.It is unknown if they were able to draw blood from the pa distal port or if the catheter was flushed through the pa lumen prior to insertion.Additionally, it was reported that on the following day, the physician's assistant had come to the unit.¿since they still had the catheter¿, the customer states they ¿sliced open the catheter with a scalpel, and a piece of metal about the size of a mechanical pencil lead, came out of the catheter.¿ she stated that ¿it does not look like the thermistor¿.It is unknown what technique was used to ¿slice open¿ the catheter nor the location at which the catheter was cut open.Subsequently, it is unknown if the reported piece of metal was a part of the catheter structure or a particulate that was present inside the catheter or introduced into the catheter as part of the customer¿s examination and dissection of the device.The lot number is unknown.There was no allegation of patient injury.Patient demographics were requested and not provided.

Manufacturer Narrative

The unknown material was sent to chemistry for further analysis.Ir spectrum of the unknown particle showed similar absorption characteristics when comparing to acrylic-like material.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.The ¿black rod¿ that was discovered at the customer facility is a known component of the paceport catheter.It is bonded in the distal side of the area of the rv probe infusion lumen as per procedure of the manufacturing process.The rod diameter was within specification per process.The unknown particle was tested under ir spectrometry and showed similar absorption characteristics to an acrylic-like material.The adhesive used to bond the rod which occludes the distal rv infusion lumen is called cyanoacrylate and would exhibit these characteristics.It should be noted that the catheter cut-down which revealed the tantalum rod was performed at the hospital by the customer, therefore, the physical state of the catheter is unable to be determined after the removal from the patient.In this case, the customer had placement difficult with the catheter and was ultimately unable to obtain a waveform.If this occurs during use, the catheter can be exchanged with minimal delay in patient care 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.

Manufacturer Narrative

Our product evaluation laboratory received one model 931f75 catheter with a single dpt, monoject limited volume syringe and a non-edwards contamination shield.As received, the catheter was cut into sections at approximately 24 cm, 20cm, 4cm and 2cm from the distal tip.The catheter body was cut and multiple lumens were exposed from approximately 4cm to 20cm.When comparing to a lab sample, the returned sections appeared to match up to the complete length of the catheter.Two pieces of black material were received detached from the catheter.A lab size 0.025 inch guidewire was able to pass through the distal lumen without difficulty.The black materials were about the same in size and each was measured to be approximately 0.15 inches long and 0.033 inches in diameter.Per the product drawings, a tantalum rod that is 0.033 inches in diameter is used to plug the rv pacing/ infusion lumen.The outer diameter of the black material was aligned to the outer diameter of a tantalum rod.The black materials appeared to be broken from one piece.The edges of the black materials appeared to match.About 3cm of the rv lumen, distal to the rv port, was exposed.Adhesive residue was found on the unknown material and at the distal end of the rv infusion port.The customer report of "metal pieces" was confirmed on evaluation; however, the customer report of an occluded distal lumen was not confirmed during evaluation.The unknown material will be sent to chemistry for further analysis and a supplemental report will be submit with the findings.

Manufacturer Narrative

Additional information was obtained on follow-up with the customer.The nurse states that when the patient was admitted from the or there was initially a pa and a cvp waveform.Shortly after being admitted and prior to the first chest x-ray (cxr), the waveform stopped appearing on the monitor.The initial cxr showed that the catheter was inserted 10cm too far in and the catheter was subsequently pulled back.A second cxr was performed and the catheter was then noted to be in good placement; however, waveforms never reappeared in the icu.There was no mention of any waveform issues in the or.The suspect swan was subsequently removed from the patient and kept with the transducer for return.

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: 9035236
• MDR Text Key: 194802484
• Report Number: 2015691-2019-03417
• 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,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• 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: 10/08/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1