MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER 6F GUIDE CATHETER; CATHETER, PERCUTANEOUS

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

Patient Problems Cardiac Arrest (1762); Chest Pain (1776); Hemothorax (1896); Perforation (2001); Blood Loss (2597)

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

Lit ref: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

During a procedure to treat a patient who presented with unstable angina a 6f launcher guiding catheter was used.When the guiding catheter advanced over the non-medtronic guidewire, reached the proximal-middle segment of the ima, the patient complained of intolerable chest pain.The guiding catheter and guidewire were immediately withdrawn.The guidewire was reintroduced into the aortic sinus and the guiding catheter was delivered to the left coronary artery, and balloon dilatation and stenting of the lm and lad was performed.The patient again complained of severe chest pain, and blood pressure began to fall.The condition deteriorated despite administration of opioid analgesics and intravenous fluids.Transthoracic echocardiography ruled out cardiac tamponade and aortic dissection.Fluoroscopy was suggestive of a right-sided pleural haemothorax.Ima angiography revealed obvious exudation of contrast in the third rib segment of the right.Bleeding was finally staunched by embolization with coils.However, the patient developed cardiac shock and suffered a cardiac arrest.The patient was successfully resuscitated and transferred to the cardiac care unit, for intubation and mechanical ventilation.The patient was treated with chest tube drainage, intravenous fluids, and blood transfusion.Subsequently, after cardiac rehabilitation, the patient was discharged from hospital 23 days after admission.

• Brand Name: LAUNCHER 6F GUIDE CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8440377
• MDR Text Key: 139457305
• Report Number: 1220452-2019-00030
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132673
• 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: 03/21/2019

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2019
• Initial Date FDA Received: 03/21/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 78 YR