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

Catalog Number DPL10020320

Device Problem Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2011

Event Type  malfunction  

Event Description

The complaint received sates that during use the deltaplush platinum microcoil 2 mm x 3 cm (dpl10020320 / g11045) was impeded in the delivery catheter.Deltaplush were stuck and they could not pull the white piece out to unlock the coil so they could advance the coil ¿this happened right after they removed from the hoop.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 sates that during use the deltaplush platinum microcoil 2 mm x 3 cm (dpl10020320 / g11045) was impeded in the delivery catheter.Deltaplush were stuck and they could not pull the white piece out to unlock the coil so they could advance the coil ¿this happened right after they removed from the hoop.There is no report of injury for the patient.The coil was returned undamaged.The most likely root cause of not being able to pull the white tab back and advance the coil was due to the sheath becoming embedded inside the v notch of the resheathing tool.This would produce a binding action between the device positioning unit (dpu) and the sheath.In this condition; significant resistance would have prevented the coil from advancing.For optimum product performance and to prevent potential complications; the instructions for use (ifu) recommends; ¿grasp the clear tab near the end of the introducer sheath body with the thumb and forefinger of your other hand.Gently pull the clear tab of the introducer sheath out and away from the re sheathing tool at a 45-degree angle to unlock the microcoil.Continue to pull the tab until an additional 0.5 to 1.0 inches (1.3 to 2.5 cm) of the translucent material is exposed.Gently fold the translucent tab towards the distal end; and firmly grasp the distal end of the re sheathing tool and the translucent tab between your thumb and forefinger; as shown in figure 3¿¿ 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 handling issues may have contributed to the reported difficulty.

• Brand Name: DELTAPLUSH - 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: 4086710
• MDR Text Key: 19590167
• Report Number: 1226348-2014-00573
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083646
• 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: 09/08/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2015
• Device Catalogue Number: DPL10020320
• Device Lot Number: G11045
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2011
• 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