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

Catalog Number CPL10020630

Device Problems Kinked (1339); Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2010

Event Type  malfunction  

Event Description

The deltaplush cerecyte microcoil could not be advanced out of the intoducer sheath.

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.The unknown microcatheter and the hemostatic valve were not returned.Located proximal 1 cm off the distal tip of the green introducer, the coil herniated outside the sheath.No mechanical sheath damage or an excessively opened skive was observed.Located distal, but adjacent to the distal end of the tip coil, the dpu has been kinked.The coil's socket ring has been bent distally approximately 90 degrees.Located at the proximal end of the coil, some of the coil damage resembles compression.Contrast-like material has been found adjacent to areas of damage on the coil which were found outside the sheath.This material dissolved in.The distal section of the coil is intact.The ball tip's radius has a damaged area.The severely damaged coil could not be functionally tested.The coil was returned severely damaged.The evidence suggests that distal interference may have cause the coil to protrude outside the sheath.In this condition, the coil could not have advanced outside the distal tip of the sheath.To what extent the contrast-like material contributed to the complaint event cannot be determined.In addition, without the return of the complete delivery system, it cannot not be determined if these components contributed to the complaint event or have additional evidence contained within.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: 4052649
• MDR Text Key: 4859001
• Report Number: 1226348-2014-00207
• 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: 09/08/2010

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: 06/28/2015
• Device Catalogue Number: CPL10020630
• Device Lot Number: G10951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2010
• Initial Date FDA Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2011
• 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