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

Catalog Number DFS10051020

Device Problem Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2011

Event Type  malfunction  

Event Description

The complaint received sates that during use the deltapaq platinum microcoil 5 mm x 10 cm (dfs10051020 / f57686) was impeded in the microcatheter.The coil would not track through the micro catheter.The coil was then successfully completely removed and set aside for return to micrus.Many additional coils were then successfully implanted.The mc was not able to be saved for return.There was 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.The complaint received sates that during use the deltapaq platinum microcoil 5 mm x 10 cm (dfs10051020 / f57686) was impeded in the microcatheter.The coil would not track through the micro catheter.The coil was then successfully completely removed and set aside for return to micrus.Many additional coils were then successfully implanted.The mc was not able to be saved for return.There was no report of injury to the patient.The coil was returned severely damaged.The evidence strongly suggests that interference inside the microcatheter most likely contributed to the coils resistance.The source and location of this interference cannot be determined.It also cannot be determined if this interference was of a fixed or detached nature.In addition; without the return of the sl-10 microcatheter 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 issues may have contributed to the confirmed event.

• Brand Name: DELTAPAQ - PLATINUM 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: 4087689
• MDR Text Key: 15995553
• Report Number: 1226348-2014-00582
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080379
• 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: 08/10/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2014
• Device Catalogue Number: DFS10051020
• Device Lot Number: F57686
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2009
• 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