FDA Adverse Event Malfunction Summary report: N

DELTAMAXX - PLATINUM MICROCOIL

MDR report key: 3941342 · Received July 17, 2014

Report

Report Number: 1226348-2014-00151
Event Type: Malfunction
Date Received: July 17, 2014
Date of Event: May 22, 2014
Report Date: May 22, 2014
Manufacturer: MICRUS ENDOVASCULAR, LLC
Product Code: HCG
PMA / PMN Number: K120274
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE COIL WAS NOT PREVIOUSLY OPENED AND THE FAILURE OCCURRED WHILE OPENING FOR USE. THE PRODUCT WAS STORED IN THE ANGIOGRAPHY ROOM APPROPRIATELY ON A SHELF. THE ACTUAL PRODUCT WAS NOT DAMAGED AND WAS USED WITH NO DELAY TO THE PROCEDURE. THE PRODUCT WAS DISCARDED AND WILL NOT BE RETURNED. BASED ON THE INFORMATION, THE EVENT COULD NOT BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE LOT NUMBER IS NOT KNOWN FOR THE COIL THEREFORE A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED AND THE EVENT COULD NOT BE CONFIRMED. THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

Additional Manufacturer Narrative · 1

THE PRODUCT WILL BE RETURNED FOR ANALYSIS, HOWEVER, IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Description of Event or Problem · 1

WHEN OPENING THE PACKAGING OF THE DELTAMAXX COIL (DMX18083520/C21259), THERE WAS TEARING IN THE MIDLINE RISKING STERILITY OF DEVICE. SAMPLE IS AVAILABLE FOR RETURN. THE PROCEDURE WAS COMPLETED WITH A SIMILAR PRODUCT (DETAILS UNKNOWN) WITH NO DELAY TO THE PROCEDURE. NO PATIENT OR VESSEL CODE INFORMATION PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
418266	DELTAMAXX - PLATINUM MICROCOIL	CNV DCS COILS	HCG	MICRUS ENDOVASCULAR, LLC	NA	C21259

Patients

Seq	Age	Sex	Outcome	Treatment
1