MAUDE Adverse Event Report: MICRUS ENDOVASCULAR, LLC DELTAPLUSH - PLATINUM MICROCOIL; CNV DCS COILS

Catalog Number DPL10020220

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2011

Event Type  malfunction  

Event Description

The complaint received states that when it was removed from the package the deltaplush platinum microcoil 2 mm x 2 cm (dpl10020220 / unk) had been contaminated with a foreign substance.When the coil was removed from its package it was noted that there was debris on the hub that looks like rust.The coil was then set to the side and not used.

Manufacturer Narrative

This mdr is being submitted as part of retrospective review as a result of a recent fda audit and with accordance to the requirements of code of federal regulations ¿ 21 cfr part 803, medical device reporting.The complaint received states that when it was removed from the package the deltaplush platinum microcoil 2 mm x 2 cm (dpl10020220 / unk) had been contaminated with a foreign substance.When the coil was removed from its package it was noted that there was debris on the hub that looks like rust.The coil was then set to the side and not used.It is confirmed that a foreign substance was found under the strain relief on the electrical connector.This type of colored substance is not used in the manufacture of this device.An outside lab has determined that this material is not blood.Therefore; it cannot be determined how or where this substance came in contact with the electrical connector.The complaint was confirmed; however, the root cause could not be determined.100% inspections are in place to prevent damaged products from leaving the facility and the dhr review confirmed that the product met specifications.No corrective action is required at this time.Review of the information does not suggest what other factors may have contributed to the confirmed event.

• Brand Name: DELTAPLUSH - PLATINUM MICROCOIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): MICRUS ENDOVASCULAR, LLC; 821 fox lane; san jose CA 95131
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC (SAN JOSE); 821 fox lane; san jose CA 95131
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 4087448
• MDR Text Key: 18923995
• Report Number: 1226348-2014-00621
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DPL10020220
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2011
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1