FDA Adverse Event Injury Summary report: N

X-PEDION

MDR report key: 6450704 · Received March 31, 2017

Report

Report Number: 2029214-2017-00340
Event Type: Injury
Date Received: March 31, 2017
Date of Event: April 6, 2012
Report Date: November 16, 2016
Manufacturer: COVIDIEN (IRVINE)
Product Code: DQX
PMA / PMN Number: K001454
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ATTEMPTS HAVE BEEN MADE TO OBTAIN SPECIFIC INFORMATION, HOWEVER, OUR ATTEMPTS HAVE BEEN UN SUCCESSFUL. VESSEL INJURY (PERFORATION ) IS A KNOWN INHERENT RISK OF ENDOVASCULAR PROCEDURE AND ARE DOCUMENTED IN OUR DEVICE¿S INSTRUCTION FOR USE (IFU). BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE, BUT RATHER A PROCEDURE RELATED EVENT. MDR RELATED TO THIS EVENT: 2029214-2017-00333 2029214-2017-00334 2029214-2017-00335 2029214-2017-00336 2029214-2017-00337 2029214-2017-00338 2029214-2017-00339 2029214-2017-00340 2029214-2017-00341.

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

CITATION: ONYX VERSUS N-BCA FOR EMBOLIZATION OF CRANIAL DURAL ARTERIOVENOUS FISTULAS. RABINOV JD1, YOO AJ, OGILVY CS, CARTER BS, HIR SCH JA. J NEUROINTERV SURG. 2013 JUL;5(4):306-10. DOI: 10.1136/NEURINTSURG-2011-010237. EPUB 2012 MAY 1. MEDTRONIC RECEIVED THE FOLLOWING REPORT: PATIENT 23 (FEMALE, 40-49 YEARS) WAS REPORTED TO HAVE TWO MICROCATHETER/ WIRE PERFORATIONS IN THE ANTERIOR INFERIOR CEREBELLAR ARTERY, WHICH HAD NO CLINICAL CONSEQUENCES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
231569	X-PEDION	WIRE, GUIDE, CATHETER	DQX	COVIDIEN (IRVINE)

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other