MAUDE Adverse Event Report: MICRUS ENDOVASCULAR, LLC CASHMERE 14 - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number CRC14071730

Device Problem Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2011

Event Type  malfunction  

Event Description

The complaint received states that the cashmere 14 cerecyte microcoil 7 mm x 17 cm (crc14071730 / g11974) was impeded in the microcatheter.The coil got stuck in the mc.(no further information provided.) there is no report of injury for the patient.

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.Cc: the complaint received states that the cashmere 14 cerecyte microcoil 7 mm x 17 cm (crc14071730 / g11974) was impeded in the microcatheter.The coil got stuck in the mc.(no further information provided.) there is no report of injury for the patient.The severely damaged 17.0 cm long coil was returned stretched 160.0 cm.The most likely root cause of the coil becoming stuck inside the microcatheter was due to a copious amount of a blood; protein; and contrast mixture found adhering to the device positioning unit (dpu) and the coil.The sl-10 microcatheter was dissected during coil removal.This rendered the microcatheter unusable for testing.However; based on the above findings it is highly unlikely that this device contributed to the complaint event.For optimum product performance and to prevent potential complications; the instructions for use (ifu) recommends; ¿to achieve optimal performance of the micrus microcoil system; it is important that a continuous infusion of an appropriate flush solution be maintained.Figure 2 illustrates the connections necessary for the micrus microcoil delivery system including a typical continuous saline flush set up with pressure bag for the catheter systems.¿ the complaint was confirmed on analysis.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 suggests that procedural issues may have contributed to the reported and confirmed events.

• Brand Name: CASHMERE 14 - 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 (SAN JOSE); 821 fox lane; san jose CA 95131
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 4056813
• MDR Text Key: 20296116
• Report Number: 1226348-2014-00210
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2011

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: 11/09/2015
• Device Catalogue Number: CRC14071730
• Device Lot Number: G11974
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/17/2011
• Initial Date FDA Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2010
• 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
• Treatment: UNK MICROCATHETER