MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR CHANDLER TRANSLUMINAL V-PACING PROBE; ELECTRODE, PACEMAKER, TEMPORARY

Model Number D98100

Device Problems Pacing Problem (1439); Defective Device (2588)

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

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.The pace port lumen was found to be restricted with blood.Continuity testing found a short condition between the proximal and distal leadwires.Cut down was performed on the probe body distal to the backform, and the short condition was confirmed to be in the backform.No short condition was observed in the probe body.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.The customer report of a pacing issue was confirmed 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.

Event Description

It was reported that the pacing wire on a swan-ganz pacing 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.It was noted that the original customer report only named a model 931f75 swan-ganz pacing catheter as the defective product in this event (previously reported under mdr # 2015691-2019-01125); however, per the edwards product evaluation lab, the reported swan-ganz pacing catheter was received with an unreported model d98100 pacing probe attached to it.Therefore, a complaint was initiated for the additional device (model d98100 pacing probe) and associated to the reported catheter (model 931f75 swan-ganz pacing catheter) from the original report.The lot number is unknown.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: CHANDLER TRANSLUMINAL V-PACING PROBE
• 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: 8491851
• MDR Text Key: 141456207
• Report Number: 2015691-2019-01225
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• PMA/PMN Number: K813521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D98100
• Device Catalogue Number: D98100
• 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