FDA Adverse Event Injury Summary report: N

RUNWAY GUIDE CATHETER

MDR report key: 2904998 · Received January 9, 2013

Report

Report Number: 2134265-2012-08319
Event Type: Injury
Date Received: January 9, 2013
Report Date: December 12, 2012
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: DQY
PMA / PMN Number: K033441
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A VESSEL DISSECTION OCCURRED. THE TARGET LOCATION FOR TREATMENT WAS THE OSTIAL RIGHT ARTERY. DURING AN UNSPECIFIED TIME OF THE PROCEDURE A RUNWAY GUIDE CATHETER WAS DEEP SEATED AND "ASSISTED IN DISSECTING AN OSTIAL RIGHT" ARTERY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
11759	RUNWAY GUIDE CATHETER	CATHETER, PERCUTANEOUS	DQY	BOSTON SCIENTIFIC - MAPLE GROVE	UNK382

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other