MAUDE Adverse Event Report: ST. JUDE MEDICAL PACEL BIPOLAR PACING CATHETER; TEMPORARY CARDIAC PACING BALLOON CATHETER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969); Cardiac Perforation (2513)

Event Type  Injury  

Event Description

The following was published in the journal of the american college of cardiology, in an article entitlled: tct-464 reducing cardiac tamponade caused by temporary pacemaker perforation in transcatheter aortic valve replacement, suppl.Supplement 80.12: b187.Elsevier inc " dalen, magnus md.This was a single-center registry of all consecutive transfemoral tavrs performed in 2014 to 2020.The main inclusion criterion was the use of a temporary pacing lead for peri-interventional pacing.The main exclusion criterion was the nonuse of a temporary pacing lead, such as a preoperatively implanted permanent pacemaker or left ventricular guidewire pacing only.Cases of cardiac tamponade were classified as pacemaker lead related, left ventricular wire related, or annular rupture related.Patients were grouped based on the type of peri-operative pacing wire used.Two events of cardiac tamponade / perforation occurred due to left ventricular wire perforation.

Manufacturer Narrative

Additional information: g3, h2, h3.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported cardiac tamponade remains unknown.

Event Description

The following was published in the journal of the american college of cardiology, in an article entitled: tct-464 reducing cardiac tamponade caused by temporary pacemaker perforation in transcatheter aortic valve replacement, suppl.Supplement 80.12: b187.Elsevier inc " dalen, magnus md.This was a single-center registry of all consecutive transfemoral tavrs performed in 2014 to 2020.The main inclusion criterion was the use of a temporary pacing lead for peri-interventional pacing.The main exclusion criterion was the nonuse of a temporary pacing lead, such as a preoperatively implanted permanent pacemaker or left ventricular guidewire pacing only.Cases of cardiac tamponade were classified as pacemaker lead related, left ventricular wire related, or annular rupture related.Patients were grouped based on the type of peri-operative pacing wire used.In total, 18 (2.2%) events of cardiac tamponade occurred, 12 (67%) were pacemaker lead related.All pacemaker lead-related cardiac tamponades occurred in the group who received a standard rv-tpw and none in the group who received rv-tppl (n¿=¿12 [2.1%] vs.N¿=¿0 [0%], p¿=¿0.022).No difference in cardiac tamponade due to other causes was seen between the groups (p¿=¿0.82).Two events (11%) of cardiac tamponade / perforation occurred due to left ventricular wire perforation requiring pericardiocentesis.Two events (0.4%) of death related to rv pacing complications.One event (0.2%) of perioperative myocardial infarction.Twelve events (2.2%) of postoperative stroke.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported patient issues remains unknown.

• Brand Name: PACEL BIPOLAR PACING CATHETER
• Type of Device: TEMPORARY CARDIAC PACING BALLOON CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15542632
• MDR Text Key: 301166045
• Report Number: 2182269-2022-00040
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K152784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2023
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention