MAUDE Adverse Event Report: MEDTRONIC MEXICO NC SPRINTER RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Catalog Number NCSP27509X

Device Problem Burst Container or Vessel (1074)

Patient Problems Aneurysm (1708); Low Blood Pressure/ Hypotension (1914); Pain (1994); Perforation (2001); Cardiac Tamponade (2226); Patient Problem/Medical Problem (2688)

Event Date 05/25/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the physician was attempting to use a nc sprinter balloon during a procedure for post dilation following successful stenting of a single lesion.The device was prepped in the usual fashion and positioned close to distal edge of the previously deployed stent and inflator device connected.While screening to fine tune the balloon, it was noted that the balloon had already been deployed (to an unknown pressure) inadvertently.It was reported that the balloon ruptured and a distal edge dissection occurred in the left main coronary artery.There was an injury to a blood vessel and haemopericardium requiring stabilization and urgent review by anaesthetics and the cardio thoracic surgery team.The patient underwent urgent drainage of the pericardial effusion and coronary artery bypass grafting.During the emergency procedure, a primary median sternotomy was performed, the right pleura was opened.Vessels were harvested from the patients right leg, pericardium was opened and the effusion drained, estimated to compromise about 500mls of blood.The saphenous vein was grafted to the lad and marginal circumflex.The patient was discharged to intensive care for 12 days post event.The reported particulars of injury include an aneurysm at the site of the perforation, pain in the sternum and rib cage, hypotension, shock and trauma, pain and numbness in the left leg, nerve entrapment syndrome involving the left leg and distress.

Manufacturer Narrative

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

• Brand Name: NC SPRINTER RX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5658758
• MDR Text Key: 45291634
• Report Number: 9612164-2016-00461
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P790017
• 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,Followup
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NCSP27509X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 59 YR