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

Catalog Number CPL10015230

Device Problem Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2011

Event Type  No Answer Provided  

Event Description

The complaint received states that the deltaplush cerecyte microcoil 1.5 mm x 2 cm (cpl10015230 / g11357) had resistance/friction resulting in loss of target lesion with the microcatheter.There was strong resistance in the mc when the coil was inserted into it.During the coil advancement; there was a feeling that the mc was pushed back.The tip of the mc ended up with coming out from the aneurysm.The procedure was ended removing the mc and the coil safely.Before this defective; other four or five coils (including one micrus: cpl100203) were deployed with no problem.There is no report of injury to 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 deltaplush cerecyte microcoil 1.5 mm x 2 cm (cpl10015230 / g11357) had resistance/friction resulting in loss of target lesion with the microcatheter.There was strong resistance in the mc when the coil was inserted into it.During the coil advancement; there was a feeling that the mc was pushed back.The tip of the mc ended up with coming out from the aneurysm.The procedure was ended removing the mc and the coil safely.Before this defective; other four or five coils (including one micrus: cpl100203) were deployed with no problem.There is no report of injury to the patient.The coil was returned severely damaged.The evidence from the damaged coil suggests that detached interference inside the microcatheter may have caused the resistance felt during coil advancement.This type of interference was most likely to have been in the form of a blood; protein; and contrast mixture.However; the exact source of this interference cannot be determined as the microcatheter and coil were returned cleaned.Concerning the microcatheter coming out of the aneurysm; it is more likely due to detached interference inside the microcatheter.This may have contributed to the kickback to occur.However; the exact source of this interference cannot be determined.The echelon 14 microcatheter passed inspection and functionality tested.Therefore; it is highly unlikely that this microcatheter; by itself; contributed to the complaint event.For optimum product performance and to prevent potential complications; the instructions for use (ifu) recommends; ¿if unusual friction is still noticed during advancement or retraction of the microcoil system; verify flush lines are open and properly pressurized.Then slowly withdraw the entire micrus microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists; withdraw and examine the delivery catheter system.¿ 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 of resistance/friction 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: 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: 4056777
• MDR Text Key: 4904614
• Report Number: 1226348-2014-00263
• 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: Other
• Type of Report: Initial
• Report Date: 03/18/2011

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2015
• Device Catalogue Number: CPL10015230
• Device Lot Number: G11357
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/18/2011
• Initial Date FDA Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2010
• 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 ECHELON 14 MICROCATHETER