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

Model Number D98100

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2017

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.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.

Event Description

It was reported that soon after the chandler pacing probe was placed, using the paceport catheter, a little fluid started accumulating in the contamination shield.The next morning, all fluid infused through the side arm of the chandler probe was noted to end up in the contamination shield and no irrigation of the lumen was possible.The catheter was left in the patient for three days and could not be removed because loss of capture would cause the heart to stop beating.The customer confirms there was no air leakage and that it is unknown if there was any blood or medication loss.There was no patient injury.Patient demographics were requested and are unknown.

Manufacturer Narrative

Our product evaluation laboratory received one chandler probe with side arm, contamination shield.The sample was attached to the paceport catheter (that was used with the chandler probe and returned by the customer) with a monoject limited volume syringe, 3ml syringe and contamination shield.The probe tip was sticking out of the rv pacing/infusion port.The side arm was pressurized with a lab syringe and water, and no backflow was observed in the contamination shield of the chandler probe.The probe tip and the body, were bent 15 inches from the tip.The bend on the probe body was aligned to the indentation location (59cm proximal to the distal tip) on the paceport catheter body, previously referenced.A blood clot was observed at the chandler probe tip.Continuity testing confirmed that both proximal and distal electrode circuits were continuous and there were no open or intermittent conditions observed.The report of occlusion was not confirmed.An engineering evaluation task was initiated to assess 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 serves 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.In this event, fluid backed up into the contamination shield of the chandler probe.It should be noted that the ifu for the chandler probe states that ¿note: when the probe is in the rv lumen, do not infuse solutions at a rate greater than 30 ml/hr because the solution may back up into the probe contamination sheath.¿ 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 part of this monthly review.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: lynn selawski ; one edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 6927810
• MDR Text Key: 89944368
• Report Number: 2015691-2017-03285
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K813521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2017
• 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: 10/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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