MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD SMALL-S, 86 CM; PERMANENT PACEMAKER ELECTRODE

Model Number 1456Q/86

Device Problem Difficult to Remove (1528)

Patient Problems Dyspnea (1816); Fever (1858); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135); Cardiac Tamponade (2226); Discomfort (2330)

Event Date 05/05/2022

Event Type  Injury  

Event Description

It was reported that the patient presented for implant of the left ventricular lead.Once the lead was placed in the target vein, the guidewire was deployed.The guidewire became stuck inside the lead and became impossible to remove, despite several attempts by the physician to force the removal.The procedure was completed with a replacement lead.On (b)(6) 2022, the patient was admitted to the emergency room with fever, dyspnea, hypotension, and pleuritic pain.Pericardial effusion was diagnosed, and the patient developed cardiac tamponade.The patient underwent pericardiocentesis and a contrast computer tomography scan was performed.The physician stated that efforts to remove the guidewire provoked a small tear into the vein.The patient was recovering in stable condition.

Manufacturer Narrative

The reported events were cardiac perforation and failure to remove guidewire.As received, a complete lead was returned in one piece.The reported event of guidewire could not be removed was confirmed.Visual inspection of the lead found that the inner coil was bunched at the connector region which was consistent with procedural damage.Blood was noted in this location.X-ray examination found a piece guidewire was stuck inside the middle portion of the lead, also consistent with procedural damage.The cause guidewire removal failure was isolated to the bunched inner coil and the presence of blood.Electrical testing did not find any indication of conductor fractures or internal shorts.The full measured s-curve hump height was within specification.

• Brand Name: QUARTET LEAD SMALL-S, 86 CM
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 14493762
• MDR Text Key: 292572041
• Report Number: 2017865-2022-10914
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734510158
• UDI-Public: 05414734510158
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1456Q/86
• Device Catalogue Number: 1456Q/86
• Device Lot Number: A000112650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2021
• 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
• Treatment: DURATA STS OPTIM ACTIVE FIXATION; HI-TORQUE 014 BMW HYDRO 3CM J; QUADRA ASSURA MP ICD; QUARTETLEAD; TENDRIL STS
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening