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

Catalog Number 4002C3260

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

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

Event Date 07/14/2014

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure in an arteriovenous fistula using a penumbra coil 400.During the procedure, the physician attempted to reposition the penumbra coil 400; however, it unintentionally detached inside the px slim delivery microcatheter.The physician removed the penumbra coil 400 and the px slim delivery microcatheter as a system.There was no report of an adverse effect on the patient.

Manufacturer Narrative

Result: the penumbra coil 400 was detached from the pusher assembly.The pet-lock was broken on the proximal end of the pusher assembly.These observations are consistent with a properly detached coil.The pull wire is no longer in the capture feature in the distal detachment tip (ddt).Conclusion: the complaint has been evaluated.The complaint indicates that the penumbra coil 400 unintentionally detached inside the pxslim while attempting to reposition the coil.Evaluation of the returned product confirmed that the penumbra coil 400 was detached from the pusher assembly however; the returned device does not show evidence of an unintentional detachment.The pet-lock was broken and retracted on the proximal end of the pusher assembly, which is consistent with a properly detached coil.The coil was intact and the pusher assembly was not damaged.Therefore, the root cause of the complaint could not be determined as the observations made during the device investigation are not consistent with the description of the event.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: 4263000
• MDR Text Key: 5109850
• Report Number: 3005168196-2014-00705
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: PM
• 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
• Report Date: 09/10/2014

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: Physician
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 4002C3260
• Device Lot Number: F39915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2014
• Initial Date FDA Received: 11/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2013
• 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 Age: 9 YR