MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

Model Number PE074F5

Device Problem Pacing Problem (1439)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation; it was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.No actions will be taken at this time.Swan-ganz pacing thermodilution (td) catheters serve as diagnostic and therapeutic tools in the management of critically ill patients.All invasive procedures inherently involve some patient risks.The physician is advised before deciding to use the catheter to consider and weigh the potential benefits and risks associated with the use of the catheter against alternative procedures.The general risks and complications associated with indwelling catheters are described in the literature.Cases of myocardial perforation associated with the use of temporary trans-venous pacing catheters have been reported.Careful repositioning and withdrawal of the catheter under fluoroscopic control is recommended.It is unknown if user or procedural factors may have contributed to 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.

Event Description

It was reported that cardiac perforation by a swan ganz pacing catheter occurred during angiographic catheterization.During catheter insertion for backup of acetylcholine provocation test, the blood pressure decreased.When noradrenalin was administered blood pressure was not improved.When the condition was checked with ultrasound scan, cardiac tamponade was confirmed.The catheter was unable to pace.The device was discarded by the hospital.Follow-up confirmed that the patient was discharged from the hospital.The patient originally had chest pain and coronary spastic angina.Patient sex is female, age 81 and weight 52.1 kg.Patient status was defined as patient is recovered.The causality between the device and the event was reported as related.The customer commented that the pacing catheter may have been inserted deeply.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION
• Type of Device: PACING CATHETER
• 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: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500249
• MDR Report Key: 10659647
• MDR Text Key: 211446917
• Report Number: 2015691-2020-13929
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K813521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PE074F5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/09/2020
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 81 YR
• Patient Weight: 52