MAUDE Adverse Event Report: ST. JUDE MEDICAL INTRODUCER

Device Problem Material Twisted/Bent (2981)

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

Event Date 08/26/2021

Event Type  malfunction  

Event Description

Manufacturer report number: 3005334138-2021-00603.During the premature ventricular contractions (pvc) procedure, when the catheter was placed, noise was noted on the electrodes 5-8.The lumen was narrow and difficult to pass due to the kinking of the sheath, and the sheath was replaced.The resistance was not confirmed at the time of replacement.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.The procedure was delayed due to these issues.

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 incident could not be conclusively determined.

• Brand Name: INTRODUCER
• Type of Device: INTRODUCER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12506117
• MDR Text Key: 273675075
• Report Number: 3005334138-2021-00604
• Device Sequence Number: 1
• Product Code: DYB
• 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
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADVISOR HD