EXCELSIOR MICROCATHETER

MDR report key: 1657103 · Received April 13, 2010

Report

Report Number: 2939204-2010-00642
Event Type: Malfunction
Date Received: April 13, 2010
Date of Event: March 29, 2010
Report Date: March 29, 2010
Manufacturer: BOSTON SCIENTIFIC - CORK
Product Code: DQY
PMA / PMN Number: UNKNOWN
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PMA# OR 510K#: K013789 AND K042568.

Additional Manufacturer Narrative · 1

PMA# OR 510K#: K013789 AND K042568. THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. VISUAL INSPECTION OF THE RETURNED DEVICE WAS UNABLE TO FIND ANY FOREIGN MATERIAL ON THE DEVICE. A FLATTENED SECTION MEASURING 2.5CM WAS NOTED 12.2CM FROM THE DISTAL END. THIS ANOMALY CAUSED RESISTANCE AS A 0.0158 MANDREL WAS ADVANCED THROUGH THE DEVICE. NO OTHER ANOMALIES WERE NOTED. THE REPORTED EVENT OF FOREIGN MATERIAL ON THE DEVICE WAS NOT CONFIRMED. BOSTON SCIENTIFIC HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENTS OF A REPORTABLE EVENT FOR THE DEVICE IN QUESTION.

Description of Event or Problem · 1

IT WAS REPORTED THAT WHEN THE DEVICE WAS REMOVED FROM THE PATIENT THERE WAS "FOREIGN MATERIAL NEAR THE GOLD LABEL". THE NATURE OF THE MATERIAL THAT WAS OBERVED WAS NOT DISCLOSED. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT WHEN THE DEVICE WAS REMOVED FROM THE PATIENT THERE WAS "FOREIGN MATERIAL NEAR THE GOLD LABEL". THE NATURE OF THE MATERIAL THAT WAS OBSERVED WAS NOT DISCLOSED. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EXCELSIOR MICROCATHETER	CATHETER, PERCUTANEOUS	DQY	BOSTON SCIENTIFIC - CORK	UNK235

Patients

Seq	Age	Sex	Outcome	Treatment
1				GDC-10 COIL (BOSTON SCIENTIFIC)