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

Catalog Number LAUNCHER(UNK)

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

Patient Problems Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Perforation (2001); ST Segment Elevation (2059)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

Literature doi: http://dx.Doi.Org/10.1016/j.Carrev.2017.03.006.If information is provided in the future, a supplemental report will be issued.

Event Description

During a procedure to recanalise the chronically occluded rca , a 7f al-1 launcher guide catheter with side holes was placed in the rca ostium and a 7f ebu3.5 launcher with side holes was placed in the lm.A femoral approach was used.A non-medtronic wire was placed in the distal diagonal beyond the subtotal occlusion of the lad but the lad itself could not be reached.Therefore, a balloon dilatation with a non-medtronic device was attempted to enable access across to the lad.The non-medtronic balloons would not cross.During these attempts, the patient complained of severe chest pain and developed hypotension.Immediate angiography of the lm showed an ostial perforation of ellis grade iii into the aortic wall.A covered stent was used to treat the perforation.Patient experienced occlusion due to covered stent positioning which was then treated.The patient was eventually discharged with improved clinical symptoms.Follow-up was uneventful until last phone contact 6 months later.

• 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: 7637041
• MDR Text Key: 112276895
• Report Number: 1220452-2018-00081
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K022764
• 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: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• 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: 06/21/2018
• 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: 76 YR
• Patient Weight: 59