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

Catalog Number CDF10030830

Device Problem Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2011

Event Type  malfunction  

Event Description

The complaint received states that during use the deltapaq cerecyte microcoil 3 mm x 8 cm (cdf10030830 / g10454) was impeded in the microcatheter and the coil was damaged.Physician having difficulty to advance the dpu after secure the green introducer section into rhv.Dpu was stuck at the middle the microcatheter.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 3 mm x 8 cm (cdf10030830 / g10454) was impeded in the microcatheter and the coil was damaged.Physician having difficulty to advance the dpu after secure the green introducer section into rhv.Dpu was stuck at the middle the microcatheter.There is no report of injury for the patient.The returned coil had compression damage at the proximal end with tissue adhering to the distal section.The evidence suggests that interference inside the microcatheter may have contributed to the resistance encountered midway through the microcatheter.The exact source of this interference cannot be determined.The headway 17 microcatheter passed inspection and functionality testing.Therefore; it is highly unlikely that this microcatheter by its self 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 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: 4087658
• MDR Text Key: 4743997
• Report Number: 1226348-2014-00642
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K080437
• 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: 05/03/2011

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: 03/25/2015
• Device Catalogue Number: CDF10030830
• Device Lot Number: G10454
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2010
• 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 MICROCATHETER