MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR DINAPT; ELECTRODE, PACEMAKER, TEMPORARY

Model Number DINAPT

Device Problems Pacing Problem (1439); Detachment of Device or Device Component (2907); No Pacing (3268)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 09/30/2019

Event Type  malfunction  

Manufacturer Narrative

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.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.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 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, the dinapt adapters came loose from the wire and stopped pacing.It was also noted that ¿the staff attempted to tape the wire and the adapters together.¿ per the warnings section of the chandler pacing probe ifu: ¿do not modify or alter the product in any way.Alteration or modification may affect patient/operator safety or product.¿ lastly, the complications section under loss of capture states: ¿loss of capture may occur due to inadvertent pulling of the probe off the endocardium, poor initial placement (probe in rv outflow tract), myocardial perforation, vigorous respirations, or patient movement.Transient loss of capture after patient movement is corrected by placing the patient in a supine position and, if necessary, increasing the threshold or repositioning the 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 part of this monthly review.Concomitant mdr report # 2015691-2019-03900.

Event Description

It was reported that during use of a chandler pacing probe, which was connected to a medtronic pacemaker, the dinapt adapters came loose from the wire and stopped pacing.Subsequently, the patient experienced a cardiac arrest and died.The icu manager stated that the staff had attempted to tape the wire and the adapters together; however, it ¿was not a good method¿.As per additional follow-up by the edwards sales rep, the dinapt adapters came loose from the chandler probe and he was told that the nursing staff ¿had issues with it and needed to secure the dinapt adapters so they did not fall out when repositioning the patient.¿ the customer reported that the event happened some time ago (estimated by the reporter as months); therefore, no other information was available about the case, including the date of occurrence, patient demographics and the lot number.The device was discarded at the time of the event.

Manufacturer Narrative

It was originally reported that the adapter had come loose from the wire and stopped pacing when they turned the patient, the patient suffered a cardiac arrest and passed away.As per information received from a follow-up conversation between the edwards product safety manager and the customer¿s icu manager, the customer clarified that since the loose connection was taped, they didn¿t immediately recognize the connection had come apart when the patient was turned.The patient did suffer a cardiac arrest; however, they reconnected the system and the patient was successfully resuscitated and had a permanent pacemaker placed the following day.The previous reports of a patient death were incorrect.

Manufacturer Narrative

Reference capa-20-00141.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: DINAPT
• 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: 9222079
• MDR Text Key: 194455252
• Report Number: 2015691-2019-03901
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DINAPT
• Device Catalogue Number: DINAPT
• 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 Outcome(s): Death