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

Catalog Number CPL10020630

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2011

Event Type  malfunction  

Event Description

The coils came out of the introducer sheet during introduction.Pre deployment in saline was performed.Failure analysis found that both coils were severely damaged.

Manufacturer Narrative

The sl-10 microcatheter and the y adaptor were not returned.The following dimensions were taken off the green introducer's distal tip:the ball tip is located 19.2 cm off the distaltip, the coils protrusion point is also located at 24.0 cm off the distal tip, and the coil protrudes outside the sheath for a length of 1.4 cm.Located at the distal tip of the green introducer is a blockage.Note the dried contrast granules.Located on and inside the sheath is a copious amount of dried contrast granules from the distal tip to the resheathing tool.Located at the distal end of the protrusion site is a copious amount of dried contrast.No mechanical sheath damage was found.Note the compression damage of the proximal end of the coil before and after removal from the sheath.This damage pattern is normally associated with distal interference when all other related conditions are absent.The coil's socket ring has been bent back into the distal diameter of the outer sheath.Note the contrast inside the outer sheath.The coil unraveled out of the soldered section.Contrast filled the section of coil emerging out of the proximal protrusion site out of the sheath.The distortion of the ball tip's radius occurred during exposure to the atmosphere and by the pressure from contact against the introducers sidewall.Except as noted the remainder of the coil is undamaged.It is important to note that both coils passed the predepolyment coil inspection in saline prior to use and both are from different lot numbers.The coil was returned severely damaged.The evidence strongly suggests that distal interference contributed to the complaint event.This interference was most likely in the form of contrast.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.¿ although a definitive conclusion cannot be made, based on the analysis, it appears that interference in the microcatheter was the primary cause of the event.Other contributing factors appear to be procedural in nature.Additionally, review of this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.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 (SAN JOSE); 821 fox lane; san jose CA 95131
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 4086821
• MDR Text Key: 21312902
• Report Number: 1226348-2014-00587
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K083646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/18/2011

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 Expiration Date: 08/21/2016
• Device Catalogue Number: CPL10020630
• Device Lot Number: G14763
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2011
• 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