MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number 4002C0925

Device Problems Difficult To Position (1467); Premature Activation (1484)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/29/2014

Event Type  Injury  

Event Description

The patient was undergoing an embolization procedure using penumbra coil 400.During the procedure, upon attempting to reposition the coil in the aneurysm, the physician noticed a small loop of coil between parent artery and the px slim catheter.The coil unintentionally detached and was retrieved successfully with a snare device.The physician placed a new px slim catheter and then tried a second coil, the physician noticed another smaller loop of coil between catheter and parent artery.Although, most of coil was in aneurysm, it detached before he wanted.The physician then used same coil pusher to insert the coil in aneurysm successfully.The procedure was completed with an additional three coils.There was no report of an adverse effect on the patient.

Manufacturer Narrative

Conclusion: the device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This mdr is associated with mdr 3005168196-2014-00345.

Manufacturer Narrative

Result: both pusher assembly proximal pet locks are still intact.The coil still has the proximal constraint ball attached.The pull-wire is still inside the capture feature of the (ddt).Conclusion: the complaint has been evaluated.The complaint indicates that the first coil detached while attempting to reposition.The second coil also detached while repositioning, but the physician was able to place the coil in the aneurysm successfully.Evaluation of the returned devices confirmed two unintentional detachments.Based on the description of the event and evaluation of the returned units, it appears that both units detached due to stretching of the flexible section at the distal end of the pusher assembly, just enough to relax the precompression in the pull wire and disengaging the pull wire from the capture feature.This allowed the coil to release from the ddt before intended detachment.Both failures of the detachment mechanism were likely related to repeated manipulations against resistance during attempts to reposition the coil.There were no observed device malfunctions.All units were within specification.In addition, all lots are tested for tensile strength and all tested units met the specification.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA COIL 400
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; 1351 harbor bay parkway; alameda, CA 94502 ; 5107483200
• MDR Report Key: 3836953
• MDR Text Key: 4407851
• Report Number: 3005168196-2014-00344
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 4002C0925
• Device Lot Number: F38056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention