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 11/17/2010

Event Type  malfunction  

Event Description

The doctor felt resistance when trying to introduce two coils of the same lot number into the rotating hemostatic valve (rhv).The coils not put in patient & were kept for return.Failure analysis revealed severe proximal damage to both returned coils.The coils will be labeled coil a and coil b and the findings will be described in two separate reports.

Manufacturer Narrative

The sl-10 microcatheter was returned, the rhv was not.Since both coils contained in this complaint are from the same lot number, this coil will be identified as coil "b".Located proximal, but adjacent to the distal tip of the skive; the dpu herniated out side the sheath.Located off the distal end of the marker band at 1.8 cm and 2.4 cm, the dpu double buckled in both places.Located at the protrusion site, the proximal end of the coil has buckled.The sheath was opened to show the buckled coil.The coil is covered in a blood, protein, and contrast mixture.The coil's socket ring has been severed at the soldered end.The coil was stretched between the intact sections.Upon receipt, the dried blood trail and coil exhibit signs of compression or snaking as viewed through the green introducer.The green introducer was full of copious amounts of blood, protein, and contrast.Using the proximal end of the guide wire, the blood mixture was pushed with significant force toward the distal tip.The blood plug could only be moved several centimeters are which time it could no longer be pushed.At this time the green introducer was dissected and the blood/contrast/protein mixture was removed.The coil was returned severely damaged and buckled back inside the sheath.The evidence suggests that distal inference inside the green introducer was produced by a plug (blood, protein, and contrast mixture) which caused the device positioning unit (dpu) to buckle and protrude outside the sheath.In this condition the coil could not be introduced into the microcatheter.The obstruction could not be removed and had to be dissected out of the introducer.The circumstances that produced this interference inside the introducer cannot be determined.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective action is taken.This is report 2 of 2 related to (b)(4).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: 4070072
• MDR Text Key: 4812871
• Report Number: 1226348-2014-00425
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/18/2010

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2014
• Device Catalogue Number: CPL10020630
• Device Lot Number: G10106
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2010
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2011
• 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