MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER (FOR FEMORAL INSERTION); CATHETER, FLOW DIRECTED

Model Number D97130F5

Device Problems Failure to Capture (1081); Product Quality Problem (1506); Structural Problem (2506); Unintended Movement (3026)

Patient Problems Therapeutic Effects, Unexpected (2099); No Consequences Or Impact To Patient (2199)

Event Date 05/22/2019

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation laboratory received two images for review.In both pictures a pacing catheter could be seen in its original packaging with the catheter tip section inside the protection sheath and placed as indicated.A device history review has also been initiated and upon completion, a supplemental report will be submit with the findings.The customer complaint could not be confirmed from the provided images.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, appropriate pacing and the occurrence of complications is well described in the literature.There are multiple failure modes that may require the exchange of a pacing catheter.Per the ifu, stretching, kinking, or forceful wiping of the catheter may result in damage.The ifu indicates: ¿model d97130f5 features a ¿j¿-tip configuration (3.5 cm radius) for femoral insertion to predispose the catheter to a stable pacing position in the apex of the right ventricle.¿ additionally, the procedure section of the ifu indicates: ¿5.With the balloon inflated, continue to advance the catheter slowly through the right atrium and into the right ventricle.Entry of the catheter into the right ventricle is indicated by a marked decrease in the amplitude of the atrial complex and an increase in the ventricular complex (see page 76, fig.1).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 15 cm 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 20 cm mark is visible.Re-inflate the balloon and advance the catheter.Once the catheter has entered the right ventricle, immediately deflate the balloon to avoid catheter flotation into the pulmonary outflow tract.Assess catheter stability.A chest x-ray film can be taken to verify catheter position.After stable pacing has been confirmed, aseptically secure the proximal end of the catheter to the insertion site to prevent undue movement, which could result in tip dislodgment and loss of capture, or catheter migration.Take care not to kink the catheter body when securing it.¿ in this event, the catheter was reported to be difficult to place and had moved to the tricuspid valve.In this complaint, it could not be determined if procedural factors or device handling may have contributed to the reported event.Udi: possible lot 61561734 - (b)(4); possible lot 61495714 - (b)(4); possible lot 61917900 - (b)(4).

Event Description

Per the customer, it was reported that they have used edwards swan-ganz pacing catheters ¿for a long time¿ but have recently noted a difference with the tip of the catheters they have received.In this instance, the catheter tip appeared to have a more pronounced curve and was difficult to place into the right ventricle.Subsequently the catheter moved into the tricuspid valve causing it to not stimulate correctly.There was no allegation of patient injury.The device was discarded; however, images were provided.The exact lot number from the suspect device is unknown, though the customer reported it came from one of three lot numbers.

Manufacturer Narrative

A device history record review was completed for all reported potential lot numbers and documented that the device met all specifications upon distribution.Possible lot 61561734, manufacturing date 11/02/2018, expiration date 10/28/2020 possible lot 61495714, manufacture date 08/20/2018, expiration date 08/14/2020 possible lot 61917900, manufacturing date 03/07/2019, expiration date 03/03/2021.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER (FOR FEMORAL INSERTION)
• 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: 8696784
• MDR Text Key: 148442330
• Report Number: 2015691-2019-02146
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K822723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D97130F5
• Device Catalogue Number: D97130F5
• 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
• Patient Age: 53 YR