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

Catalog Number 4002C0935

Device Problems Detachment Of Device Component (1104); Retraction Problem (1536); Physical Resistance (2578)

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

Event Date 11/13/2014

Event Type  malfunction  

Manufacturer Narrative

Result: the penumbra coil 400 was detached from the pusher assembly.The pet lock on the proximal end of the pusher assembly was intact.The proximal constraint sphere was still intact with the coil.The pull wire was inside the distal detachment tip (ddt).The ddt was not damaged.The inner diameter of the ddt was measured within specification.The outer diameter of the coil, proximal constraint sphere, pusher assembly, and the pull wire were measured within specification.Conclusion: the complaint has been evaluated.The complaint indicates that resistance was felt during the retraction of the coil, then it detach inside the px slim microcatheter.Evaluation of the returned product confirmed that the penumbra coil 400 was detached from the pusher assembly.This detachment might have occurred due to the force used during retraction of the coil and the resistance felt.The force use could have likely exceeded the compression strength of the ddt capture features mechanism.This is what keeps the coil intact with the pusher assembly.The outer diameter of the coil, pusher assembly, pull wire, and proximal constraint sphere were measured within specification.It is not clear if the px slim delivery microcatheter was damaged and caused resistance during the retraction of the coil.The px slim delivery microcatheter was not returned for evaluation.The root cause of this complaint cannot be determined.These devices are 100% functional tested during process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a coil embolization procedure using a penumbra coil 400 and a px slim delivery microcatheter.During the procedure, the physician experienced resistance while retracting the coil through the px slim.The coil unintentionally detached within the pxslim and both devices were removed from the patient.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 3005168196-2014-00919.

• 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: 4371996
• MDR Text Key: 17518308
• Report Number: 3005168196-2014-00918
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 4002C0935
• Device Lot Number: F42916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2014
• 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