MAUDE Adverse Event Report: MEDTRONIC, INC COUGAR XT GUIDE WIRE - UNK; WIRE, GUIDE, CATHETER

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

Patient Problems Hematoma (1884); Blood Loss (2597)

Event Date 11/10/2016

Event Type  Injury  

Manufacturer Narrative

Literature reference: doi: 10.1002/ccd.26835.If information is provided in the future, a supplemental report will be issued.

Event Description

This study discusses the shopping trial (show how options in price for procedures can be influenced greatly) to see if percutaneous coronary intervention (pci) procedures can be performed at a lower cost in a single institution.Cougar guidewires and resolute drug eluting stent devices were amongst the devices used to treat patients.All 5 recorded macce events occurring in both pre- and post-intervention patient cohorts were post-pci procedure bleeding events.Four events were drops in hemoglobin values, 1 event was a hematoma.There were no deaths, additional mi, or strokes in these patients.

• Brand Name: COUGAR XT GUIDE WIRE - UNK
• Type of Device: WIRE, GUIDE, CATHETER
• 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: 7316190
• MDR Text Key: 101587497
• Report Number: 1220452-2018-00022
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2018

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: 02/06/2018
• Initial Date FDA Received: 03/06/2018
• 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 Age: 64 YR