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

Catalog Number	400SMTSFT0515
Medical Device Problem Codes	Material Twisted/Bent (2981); Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra smart coils (smart coils).During the procedure, contrast accidently got on the pusher assembly of the smart coil.Consequently, the pusher assembly became hung-up and bent while advancing through the non-penumbra microcatheter; therefore, the smart coil was removed.The procedure was completed using a new smart coil and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the follow-up #01 and is being included on this follow-up #02 mfr report.If follow-up, what type?.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra smart coil (smart coil) pusher assembly.The pusher assembly was kinked approximately 45.0 thru 47.5 cm from its proximal end.The embolization coil was undamaged and intact with its pusher assembly.Conclusions: evaluation of the returned smart coil confirmed that the pusher assembly was kinked.If the device is advanced against resistance, damage such as a kinked pusher assembly may occur.The contrast identified in the complaint description may have contributed to the resistance.During the functional test, the smart coil could not be advanced through its introducer sheath due to the pusher assembly kinks.Penumbra coils are visually 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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9304923
• Report Number: 3005168196-2019-02081
• Device Sequence Number: 11288816
• Product Code: HCG
• UDI-Device Identifier: 00814548014944
• UDI-Public: 00814548014944
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2019
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/26/2024
• Device Catalogue Number: 400SMTSFT0515
• Device Lot Number: F88708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 11/12/2019; 01/14/2005
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 11/12/2019; 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005