FDA Adverse Event Injury Summary report: N

REFLEX CATHETER

MDR report key: 5351439 · Received January 7, 2016

Report

Report Number: 2029214-2016-00011
Event Type: Injury
Date Received: January 7, 2016
Date of Event: November 3, 2015
Report Date: December 10, 2015
Manufacturer: COVIDIEN (IRVINE)
Product Code: DQY
PMA / PMN Number: K110055
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE MODEL AND LOT NUMBERS WERE NOT REPORTED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, OUR INVESTIGATION WAS LIMITED AND THE UNDERLYING ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, VASOSPAMS IS A KNOWN INHERENT RISK OF ENDOVASCULAR PROCEDURE AND IS DOCUMENTED IN THE NAVIEN CATHETER INSTRUCTION FOR USE.. ATTEMPTS WERE MADE TO OBTAIN THE DEVICE INFORMATION THAT WERE UNSUCCESSFUL. WHEN ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE PROVIDED.

Description of Event or Problem · 1

MEDTRONIC RECEIVED REPORT THROUGH CLINICAL DATA REVIEW THAT A PATIENT EXPERIENCED VASOSPASM DURING A MECHANICAL THROMBECTOMY PROCEDURE FOR A ACUTE ISCHEMIC STROKE DUE TO A LARGE THROMBUS IN THE DISTAL BASILAR ARTERY.. IT WAS REPORTED THAT AFTER SUCCESSFUL RECANALIZATION OF THE BASILAR ARTERY WHICH WAS EVIDENT BY THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) OF 3, THE PHYSICIAN OBSERVED SOME SLOWING IN THE MID VERTEBRAL ARTERY ON THE LEFT WHERE THE NAVIEN CATHETER WAS PLACED. THE PHYSICIAN INJECTED 10MG OF VERAPAMIL THROUGH THE CATHETER AND RESTORED THE FLOW. FINAL ANGIOGRAM REVEALED GOOD FLOW IN THE VERTEBRAL ARTERY. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THIS PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
10858	REFLEX CATHETER	CATHETER, PERCUTANEOUS	DQY	COVIDIEN (IRVINE)

Patients

Seq	Age	Sex	Outcome	Treatment
1	00081 YR		Required Intervention