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

Catalog Number CDF10025030

Device Problem Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2011

Event Type  malfunction  

Event Description

The complaint received states that during use the deltapaq cerecyte microcoil 2.5 mm x 10 cm (cdf10025030 / f48931) became impeded in the microcatheter and was damaged.Upon introduction into the microcatheter the deltapaq 2.5 x10 immediately became stuck.No more than 2cm of coil length was introduced.It was then removed and set aside.A second coil was then used successfully thru the same catheter system.There is no report of injury for 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.The complaint received states that during use the deltapaq cerecyte microcoil 2.5 mm x 10 cm (cdf10025030 / f48931) became impeded in the microcatheter and was damaged.Upon introduction into the microcatheter the deltapaq 2.5 x10 immediately became stuck.No more than 2cm of coil length was introduced.It was then removed and set aside.A second coil was then used successfully thru the same catheter system.There is no report of injury for the patient.The distal section of the device positioning unit (dpu with the attached coil was returned mechanically severed.The proximal end of the coil was severely damaged.But the first eleven secondary windings off the ball tip are undamaged.Due to the severed dpu and the severely damaged coil; no laboratory testing could be performed.Therefore; the exact root cause of the coil becoming stuck during introduction cannot be determined.However; the evidence suggests that interference inside the microcatheter may have contributed to the resistance of the coil during introduction.In addition; without the return of the sl-10 microcatheter and the hemostatic valve used in the procedure; it cannot be determined if this component contributed to the complaint event.The complaint 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 and handling issues may have contributed to the confirmed event.

• Brand Name: DELTAPAQ - 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: 4087664
• MDR Text Key: 4739306
• Report Number: 1226348-2014-00646
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2011

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: 12/30/2013
• Device Catalogue Number: CDF10025030
• Device Lot Number: F48931
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2008
• 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 MICROCATHETER