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

Model Number 931F75

Device Problems Pacing Problem (1439); Defective Device (2588); No Pacing (3268)

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

Event Date 02/07/2019

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.A device history record review was completed and documented that the device met all specifications upon distribution.Udi # (b)(4).

Event Description

It was reported that the pacing wire on a swan-ganz catheter was defective.The pacing wire did not conduct current and did not pace when placed in the patient.The issue was solved by exchanging it for a different pacing wire.There was no further information available.There was no allegation of patient injury.Patient demographics were requested and not provided.

Manufacturer Narrative

Per the product evaluation lab, the reported model 931f75 swan-ganz pacing catheter was received with an unreported model d98100 pacing probe attached to it.The customer did not provide any additional information regarding how the pacing probe relates to the complaint and what the alleged malfunction is reported to be.An additional complaint was opened for the pacing probe in association with the reported catheter in this complaint.Our product evaluation laboratory received one model 931f75 swan-ganz pacing catheter with a model d98100 pacing probe and monoject limited volume syringe.As received, the model d98100 pacing probe was attached to the swan-ganz pacing catheter and was also noted to be stuck to the pace port lumen of the returned swan-ganz pacing catheter.Cut down was performed on the catheter body and the pace port lumen was found to be restricted with blood.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.No visible damage was observed from the catheter body.No defect was found on evaluation.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Swan-ganz pacing thermodilution (td) catheters used in conjunction with a chandler transluminal v-pacing probe serve as diagnostic and therapeutic tools in the management of critically ill patients.There are multiple failure modes that may require the exchange of the catheter or the pacing probe.There is the potential that user or procedural factors may have played a role in this event.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 a part of the monthly review.Concomitant product report (mdr) #: 2015691-2019-01225.

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: 8469706
• MDR Text Key: 140920828
• Report Number: 2015691-2019-01125
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2020
• Device Model Number: 931F75
• Device Lot Number: 61511140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1