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

Catalog Number DFS10031020

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2010

Event Type  malfunction  

Event Description

When attempting to "pre-test' two deltapaq platinum microcoils, the devices could not plug into the ecb cable.After the first device would not connect, a new ecb cable was opened, however the problem still existed.Both coils were placed to the side for return to micrus, and an additional 3x10 coil was successfully implanted.There was no patient injury.

Manufacturer Narrative

(b)(6).Complaint conclusion: the device was returned for analysis.The electrical connector was returned with both posts pushed back into the strain relief.No adhesive or other interference was found on the inside cavity walls of the electrical connector.Multiple connecting cables from different lot numbers did fit loosely inside the dpu's electrical connector.The chamfer is incomplete on both the left and right posts.It is evident from the tooling marks, that the chamfer tooling was most likely damaged and/or burred.The electrical connector is missing the lead-in chamfer on the outside edge of the cavity.However, this did not have any effect on inserting the connecting cable's plug past this area.There is an out of round condition between the strain relief's inside diameter and the electrical connector's outside diameter.Engineering has determined that the dpu's electrical connector's posts are misaligned.The complaint was confirmed based on product analysis.The most likely root cause of the device positioning unit¿s (dpu) failure to connect into the enpower control cable (ecb) was due to the misalignment of the dpu¿s electrical connector¿s posts and the missing lead-in chamfer located at the inside diameter of both electrical posts of the dpu¿s electrical connector.Capa (b)(4) has been issued to address this complaint.This mdr is being submitted as part of a retrospective review as the result of a recent fda audit and with accordance to the requirements of code of federal regulations - 21 cfr part 803, medical device reporting this is one of 2 mdrs submitted for patient identifier # (b)(4).

• Brand Name: DELTAPAQ - 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; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 4055515
• MDR Text Key: 4734654
• Report Number: 1226348-2014-00217
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/17/2010

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2015
• Device Catalogue Number: DFS10031020
• Device Lot Number: G10969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2010
• Initial Date FDA Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1