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

Catalog Number 400SMTXSFT1H02

Device Problems Device Contamination with Chemical or Other Material (2944); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with the pusher assembly distal detachment tip (ddt) and was undamaged.The smart coil was able to advance through its introducer sheath and a demonstration microcatheter without resistance.Conclusions: evaluation of the returned smart coil revealed a functional device.The device was undamaged.During functional testing the smart coil was able to advance through its introducer sheath and a demonstration microcatheter without resistance.The complaint reported that a white foreign substance was found and cleaned from the returned smart coil.It is likely that this foreign substance contributed to the reported resistance experienced during the procedure.The root cause of this substance was unable to be determined.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.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 in the anterior communicating artery (acom) using penumbra smart coils (smart coils).During the procedure, the physician successfully deployed four coils into the target vessel using a non-penumbra microcatheter.Upon advancement of the fifth smart coil, the physician felt resistance and decided to remove the smart coil and introducer sheath together from the microcatheter.The procedure was completed using two other coils and the same microcatheter.There was no report of an adverse effect to the patient.It should also be noted that, upon inspection of the smart coil and pusher assembly after the procedure, a penumbra employee found an unknown white scaly substance on the pusher wire.The penumbra employee then cleaned the pusher wire and was able to advance the smart coil with little resistance.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 8238355
• MDR Text Key: 132814597
• Report Number: 3005168196-2019-00049
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015224
• UDI-Public: 00814548015224
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2023
• Device Catalogue Number: 400SMTXSFT1H02
• Device Lot Number: F85166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Is the Reporter a Health Professional?: Yes
• 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: 12/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2018
• 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: 52 YR
• Patient Weight: 56