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

Catalog Number 400SMTXSFT2H04

Device Problems Peeled/Delaminated (1454); Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2019

Event Type  malfunction  

Manufacturer Narrative

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 report is associated with mfr report number: 3005168196-2019-00276.

Event Description

The patient was undergoing a coil embolization procedure in the vertebral arter (va) using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).It was reported that the patient had a mildly tortuous vertebral artery.During the procedure, the physician successfully placed multiple coils and a smart coil using a non-penumbra microcatheter.The physician was unable to detach another smart coil using the handle and therefore, the smart coil was removed.The procedure was completed using a new smart coil, a new handle, and additional coils.There was no report of an adverse effect to the patient.

Event Description

The patient was undergoing a coil embolization procedure in the vertebral artery (va) using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).It was reported that the patient had a mildly tortuous vertebral artery.During the procedure, the physician successfully placed multiple coils and a smart coil using a non-penumbra microcatheter.The physician was unable to detach another smart coil using the handle and therefore, the smart coil was removed.It was reported that the black coating on the proximal end of the pusher assembly was peeling off.The procedure was completed using a new smart coil, a new handle, and additional coils.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following sections are being updated based on additional information provided by the distributor on 02/20/2019: describe event or problem.Device code 2.Results: the pet lock was broken and retracted approximately 0.3 cm on the proximal end of the pusher assembly.The pusher assembly had bends approximately 28.0, 48.0, 81.0, and 107.0 cm from the proximal end.The embolization coil was intact with its pusher assembly and had offset coil winds.Conclusions: evaluation of the returned smart coil revealed that the pet lock was broken and not completely retracted.If the pet lock is broken during an attempt to detach the smart coil using the handle, and the pull wire is not completely retracted out of the ddt, the embolization coil may not detach from its pusher assembly.In addition, that patient¿s tortuous anatomy may have also contributed to the reported detachment issue.During the functional test, the smart coil pusher assembly was straightened on the table and the returned handle was attached to the proximal end and actuated.The smart coil successfully detached from its pusher assembly without an issue.The root cause of the reported inability to detach the coil was unable to be determined.Evaluation of the returned handle revealed that the device was functional.The handle was functionally tested in the handle fixture and passed within specification.In addition, the returned handle was used during the functional test of the returned smart coil and the coil was successfully detached without an issue.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are visually inspected and functionally tested during incoming inspection by quality.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 1.3005168196-2019-00276.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8345268
• MDR Text Key: 136609193
• Report Number: 3005168196-2019-00275
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015323
• UDI-Public: 00814548015323
• Combination Product (y/n): Y
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2021
• Device Catalogue Number: 400SMTXSFT2H04
• Device Lot Number: F72703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1