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

Catalog Number LAUNCHER(UNK)

Device Problems Failure to Deliver (2338); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Perforation (2001); Discomfort (2330); Pseudoaneurysm (2605)

Event Date 02/22/2018

Event Type  Injury  

Manufacturer Narrative

Literature reference: doi.Org/10.1155/2018/6790120.If information is provided in the future, a supplemental report will be issued.

Event Description

Three months after an initial coronary intervention a patient was returned for a planned pci of a distal rca stenosis.A 6 french al 0.75 guide catheter (medtronic) was advanced over an exchange length 0.035 j-wire, but could not be delivered to the ascending aorta due to resistance in the brachiocephalic artery.The guide was removed and exchanged for a 6 french jr 4 guide catheter (medtronic) which was easily advanced into the ascending aorta and used to engage the ostium of the rca without complication.Immediately following completion of the procedure, the patient reported an episode of chest discomfort, a new cough, bilateral expiratory wheezes, and respiratory stridor.A transient episode of hypotension was noted but resolved without intervention.Based on the chest radiography finding, trans-esophageal echocardiography (tee) was urgently performed.Echocardiography revealed no evidence of aortic dissection, but vague echodensities were noted anterior to the right heart suggestive of a hematoma.The chest ct revealed a large hyperdense region surrounding the trachea suggestive of an anterior mediastinal hematoma, resulting in severe airway compression.A repeat ct of the chest with administration of intravenous contrast was notable for a small pseudoaneurysm arising from the inferior aspect of the brachiocephalic artery, as well as significant narrowing of the distal trachea below the endotracheal tube.The decision was made to pursue endovascular repair of the brachiocephalic artery pseudoaneurysm and presumed site of vascular perforation.Angiography of the brachiocephalic artery was performed, which confirmed the presence of a brachiocephalic artery pseudoaneurysm.A non-medtronic covered stent was deployed across the neck of the pseudoaneurysm.Following the intervention, there was an excellent angiographic result with preserved subclavian and carotid runoff.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: LAUNCHER UNK 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: 7702245
• MDR Text Key: 114424594
• Report Number: 1220452-2018-00093
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LAUNCHER(UNK)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• 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: 69 YR
• Patient Weight: 67