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

Catalog Number CPL10015330

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2010

Event Type  malfunction  

Event Description

There was resistance when the deltaplush coil was inserted into a microcatheter.When the coil was pushed with force; the tip of the delivery wire got kinked.Product analysis revealed that the coil was damaged.

Manufacturer Narrative

(b)(6).Complaint conclusion: the unit was returned cleaned.The coil was returned only in a plastic bag packed in a box with other boxed devices.The coil was unsheathed, unprotected, and severely damaged.Located off the distal end of the marker band, there is buckling at 2mm and 1.4cm.The coil¿s socket ring has been severed at the soldered section.There was tissue adhering to the severed socket ring and at the distal tip of the soldered section.The proximal end of the coil is severely damaged and is in a multi-buckled state.There are remnants of a substance found adhering to the ball tip.Only the proximal section of the coil is damaged, the remainder of the coil is intact.The unit was too severely damaged for testing.The proximal end of both the device positioning unit (dpu) and the coil were returned severely buckled.The evidence suggests that distal interference inside the microcatheter during insertion most likely contributed to the resistance encountered.Tissue was found adhering to the coil at all the buckled sections.However, the exact source of the interference inside the microcatheter cannot be determined.In addition, without the return of the microcatheter and the hemostatic valve used in the procedure, it cannot be determined if these components contributed to the complaint event.This mdr is being submitted as part of a retrospective review as the result of a recent fda audit and with accordance to the requirments 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: 4055969
• MDR Text Key: 4812086
• Report Number: 1226348-2014-00240
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/29/2010

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: 10/04/2015
• Device Catalogue Number: CPL10015330
• Device Lot Number: G11708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2010
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2010
• Initial Date FDA Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2010
• 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