MAUDE Adverse Event Report: MICRUS ENDOVASCULAR, LLC HELIPAQ 10 - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number CHE10052030

Device Problems Detachment Of Device Component (1104); Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2011

Event Type  malfunction  

Event Description

The complaint received states that during use the helipaq 10 cerecyte microcoil 5 mm x 20 cm (che10052030 / f49549) was impeded in the microcatheter and the coil prematurely detached when it was pulled back.There was resistance during advancement inside the mc.The coil got stuck at the tip of the mc.The coil detached when it was pulled back to remove from the mc.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.Cc: the complaint received states that during use the helipaq 10 cerecyte microcoil 5 mm x 20 cm (che10052030 / f49549) was impeded in the microcatheter and the coil prematurely detached when it was pulled back.There was resistance during advancement inside the mc.The coil got stuck at the tip of the mc.The coil detached when it was pulled back to remove from the mc.There is no report of injury for the patient.The most likely root cause of the coil¿s resistance inside the microcatheter was due to the selection of an incompatible 18 series microcatheter that was used with a 10 series microcoil system.For optimum product performance and to prevent potential complications; the instructions for use (ifu) recommends; ¿proper selection of the appropriately sized microcatheter is required to avoid damage to the micrus microcoil system and to minimize potential complications.The micrus microcoil 10 system is compatible with microcatheters with inner lumen diameters ranging from 0.014 to 0.017 in (0.356 to 0.432 mm).¿ the inner lumen of a renegade microcatheter is 0.021.¿ although not complaint related; it was found that the resheathing tool was advanced over the proximal end of the green introducer.For optimum product performance and to prevent potential complications; the instructions for use (ifu) recommends; ¿return to the infusion microcatheter¿s rhv.Loosen the rhv and gently slide the introducer tip out from the rhv; over the dpu wire.Once a small section of the exposed dpu wire is visible; tightly grasp it with the thumb and forefinger of the same hand that is holding the rhv.Using the thumb and forefinger of your other hand; grasp the introducer tip; slowly slide it away from the rhv over the dpu wire.Continue sliding the introducer tip until just before the tip reaches the distal end of the re sheathing tool; leaving approximately 1 inch of the unsheathed introducer sheath still visible.¿ 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: HELIPAQ 10 - 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: 4065999
• MDR Text Key: 16446118
• Report Number: 1226348-2014-00392
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K022420
• 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: 05/10/2011

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2014
• Device Catalogue Number: CHE10052030
• Device Lot Number: F49549
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2011
• Initial Date FDA Received: 09/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2009
• 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 18 MICROCATHETER