MAUDE Adverse Event Report: MICRUS ENDOVASCULAR, LLC HELIPAQ 18 - PLATINUM MICROCOIL; CNV DCS COILS

Catalog Number HEL18143020

Device Problems Crack (1135); Delivery System Failure (2905)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2014

Event Type  malfunction  

Event Description

Before use in the patient, the helipaq 18 platinum microcoil system (hel18143020/c12966) broke when it was being removed from the packaging.The procedure was completed with same like product.A picture of the event was provided depicting a bend right below hub/delivery system section.After the event, the account tried to connect it with the connecting cable, but the green light on the detachment box would not shine.Thus, it would be clear that a detachment wasn't possible.The hub was stuck a little bit more than the surgeon was used to, but no additional force or manipulation was used to remove the device from the plastic hoop/clip.There were no visible damages on the outer or inner package, and prior to removing the device from the plastic container no damages were noticed on the plastic hoop (specially the area holding the hub).The procedure was delayed 2 minutes, but there was no adverse reported, and an echelon 10 microcatheter was used for the basilar artery aneurysm.The product was stored per label instructions and the component will be return for analysis.After the event, other than what was reported, no damages were noticed on the device (kink, bend, stretched, fracture, separate, coil ring fracture or bent, etc.).There was no clinical impact to the patient due any delay, and the device was discarded.No further information was available.

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The product will be returned for analysis, but it has not been received to date.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Please note that the device was not returned for analysis, and it was discarded.Before use in the patient, the helipaq 18 platinum microcoil system (hel18143020/c12966) broke when it was being removed from the packaging.The procedure was completed with same like product.A picture of the event was provided depicting a bend right below hub/delivery system section.After the event, the account tried to connect it with the connecting cable, but the green light on the detachment box would not shine.Thus, it would be clear that a detachment wasn¿t possible.The hub was stuck a little bit more than the surgeon was used to, but no additional force or manipulation was used to remove the device from the plastic hoop/clip.There were no visible damages on the outer or inner package, and prior to removing the device from the plastic container no damages were noticed on the plastic hoop (specially the area holding the hub).The procedure was delayed 2 minutes, but there was no adverse reported, and an echelon 10 microcatheter was used for the basilar artery aneurysm.The product was stored per label instructions and the component will be return for analysis.After the event, other than what was reported, no damages were noticed on the device (kink, bend, stretched, fracture, separate, coil ring fracture or bent, etc.).There was no clinical impact to the patient due any delay, and the device was discarded.No further information was available.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Without the product, the reported event could not be confirmed; additionally, it appears that during removal of the device from the hoop there was additional manipulation to remove the device from the plastic hoop that may have contributed to the event.Additionally, the dhr indicated that this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.

• Brand Name: HELIPAQ 18 - 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; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014
• MDR Report Key: 3757898
• MDR Text Key: 4480858
• Report Number: 1226348-2014-00093
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K070707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2017
• Device Catalogue Number: HEL18143020
• Device Lot Number: C12966
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR