MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION; ELECTRODE, PACEMAKER, TEMPORARY

Model Number PE074F5

Device Problem Pacing Problem (1439)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2021

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation results when received.

Event Description

It was reported that it became unable to pace on the 32nd day of use.The catheter was inserted onto the patient on (b)(6) 2021 and placed until (b)(6) 2021.It was unable to be confirmed how many times pacing was performed during this time.It is unknown what kind of action was taken after the catheter removal.Information such as what kind of surgery or examination the catheter was used for or if the patient had cardiac conduction defect is unknown.The patient demographic information was requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

Additional information was obtained from the customer memo included with the returned product: the female patient, age 81, had a complete atrioventricular block (cavb).The catheter was placed until 12 dec 2021.The catheter was replaced since it became unable to pace.The chronology was as follows.09.17.2021 papillary muscle rupture of mitral valve and free wall rupture occurred due to acute myocardial infarction (ami).Mitral valve replacement (mvr) and hemostasis were performed.10.27.2021 a pacing catheter was inserted for the complete atrioventricular block (cavb).11.09.2021 the pacing catheter was replaced due to suspected infection.The catheter was inserted from the right subclavian vein.The tip of the catheter was found severely bent when the catheter was inserted.One bipolar pacing catheter with attached cap at gate valve was returned for evaluation.Clotted blood was observed from the catheter and inside the balloon.The reported issue of unable to pace was confirmed.Continuity testing confirmed a full open condition in the proximal circuit.The distal circuit was found to be continuous.A cut down of the catheter body was performed just proximal side of the proximal electrode to expose the pacing lead wires.Continuity testing confirmed a full open condition around catheter tip.It was also confirmed that the proximal circuit was continuous from just proximal side of the proximal electrode to proximal connector pin.As received, catheter tip was bent.The balloon inflated but failed to maintain its inflation due to leakage from a gap around circumference between proximal electrode and catheter body.Per ifu the incidence of complications increases significantly with in dwelling periods longer than 72 hours.No visible damage was observed from balloon and windings.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 13077809
• MDR Text Key: 283093752
• Report Number: 2015691-2021-07013
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K813521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PE074F5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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 Sex: Female