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

Catalog Number CPL10015330

Device Problems Physical Resistance (2578); Deformation Due to Compressive Stress (2889)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2011

Event Type  malfunction  

Event Description

The physician felt a lot of resistance with two deltaplush cerecyte microcoils (both lot g11864) about half way up a non-codman microcatheter.There was no serious injury as a result of the event.

Manufacturer Narrative

(b)(6).This is 1 of 2 mdrs being submitted for patient identifier (b)(6).Complaint conclusion: the device was returned for analysis.Located 1.7cm from the distal section of the marker band, the device positioning unit (dpu) was buckled.There was a copious amount of contrast-like material adhering to the buckled section.Located 2.4cm distal to the marker band¿s distal end, there was a second buckled section of the dpu.The proximal end of the coil was severely damaged, partially due to compression.The coil¿s socket ring was bent and was shifted to the side and down under the other sheath.The distal section of the coil was undamaged.Concerning the returned excel microcatheter, the hub to microcatheter junction had material protruding into the inner diameter causing an out-of-round condition.At the distal tip of the microcatheter, the inner diameter exhibited an out-of-round or ovalized condition.There was a blockage located approximately midway along the length of the microcatheter, consisting of a mixture of blood, protein, and contrast-like material.When the blockage was dissolved, a proteinaceous mass remained.The excel microcatheter was then cleaned for testing.A deltaplush coil from the same lot number as the complaint coil was used in the test.The coil was advanced multiple times through and out the distal tip of the returned excel microcatheter with no resistance encountered.The protruding material at the hub to microcatheter connection and the ovalized distal tip did not impair the microcoil¿s advancement inside the microcatheter during this test.The evidence suggests that distal interference inside the microcatheter most likely contributed to the coil becoming stuck inside the microcatheter.This blockage inside the microcatheter was most likely the blood, protein, and contrast plug located at the point where the coil became stuck.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.

• Brand Name: DELTAPLUSH - CERECYTE 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: 4057528
• MDR Text Key: 4864366
• Report Number: 1226348-2014-00305
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• 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: Health Professional
• Type of Report: Initial
• Report Date: 01/19/2011

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: 11/15/2015
• Device Catalogue Number: CPL10015330
• Device Lot Number: G11864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2011
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2011
• Initial Date FDA Received: 09/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2011
• 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