MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ VIP+ TRI-LUMEN INFUSION THERMODILUTION CATHETER; SWAN-GANZ FLOW DIRECTED THERMODILUTION CATHETER

Model Number 834F75

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2022

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis however, it has not yet been received.Upon 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 via medwatch report 2200710000-2022-8012 that a model 834f75 swan ganz catheter was placed for use with a pulmonary autograft ross procedure with pulmonary valve autograft.Per the report, after reviewing the patient's evening chest x-ray, it was noted that the catheter was malpositioned and coiled on itself, and the icu nursing staff noted difficulty with medication administration through the line.At approximately 1230 in the morning, they attempted to withdraw and reposition the catheter being conscientious that the catheter was crossing the patient's recent operative site and homograft.Air was withdrawn from the balloon until no further air was able to be withdrawn, and no blood was noted in the pa line.The catheter was successfully withdrawn approximately 7cm with little resistance into the right ventricle and positioning was confirmed by waveform.At that time, the patient developed ectopy and the catheter was repositioned slightly with resolution of the ectopy.There was minimal blood noted at the balloon port.Re-inflation of the balloon was attempted to re-float the catheter but only approximately 1cc of air was instilled into the balloon before encountering slight resistance and the balloon was not inflated any further.Upon deflating the balloon, blood was noted to be withdrawn from the balloon port.The decision was therefore made to withdraw the catheter.Upon retrieval, it was noted that the entire distal balloon of the catheter had been sheared off.The patient remained hemodynamically stable at the time without any increase in his chest tube output.It was confirmed with the reporter that the patient also remained stable throughout the rest of the hospital course to discharge.The lot number of the suspect device was unknown.

Manufacturer Narrative

The customer did not respond to multiple attempts to return the device for evaluation.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 was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.As part of the manufacturing process, 100 percent of the units go through a balloon inflation and visual inspection.Based on the procedures, if the unit had a balloon deflation or inflation defect, it would have been captured during this inspection process.Additionally, the ifu contains important instructions on how to avoid damaging the catheter body on insertion, as follows precaution catheter looping may occur when excessive length has been inserted, which could result in kinking or knotting see complications.If the right ventricle is not entered after advancing the catheter 15cm beyond entry into the right atrium, the catheter may be looping, or the tip may be engaged in a neck vein with only the proximal shaft advancing into the heart.Deflate the balloon and withdraw the catheter until the 20cm mark is visible.Reinflate the balloon and advance the catheter.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

Manufacturer Narrative

Our product evaluation lab received, one model 834f75 catheter, with a monoject limited volume syringe and non-edwards contamination shield.The catheter balloon was found to be torn from the proximal and distal bonding sites.The central area of the balloon latex was missing.Residual latex was observed, from the distal and proximal bonding sites.The rv infusion lumen was occluded with blood.All other through lumens were patent without any leakage or occlusion.No visible damage or inconsistency was observed, from the catheter body.The customer report of balloon of the catheter had been sheared off was confirmed, on evaluation.An engineering evaluation has been initiated to assess for any manufacturing-related processes, which could be correlated to the complaint.

• Brand Name: SWAN-GANZ VIP+ TRI-LUMEN INFUSION THERMODILUTION CATHETER
• Type of Device: SWAN-GANZ FLOW DIRECTED THERMODILUTION CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 14760653
• MDR Text Key: 301800568
• Report Number: 2015691-2022-06301
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K810352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 834F75
• Device Catalogue Number: 834F75
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: White