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

Catalog Number	400SMTSFT0408
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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, the physician successfully detached a smart coil using a non-penumbra microcatheter.While retracting to remove the pusher assembly, the physician felt resistance and the pusher assembly became "hung up" at the tip of the microcatheter.The physician was able to remove the pusher assembly but found that the tip was damaged and a little piece was "flared up".The procedure was completed using additional smart coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was separated on the proximal end of the pusher assembly.Kinks were present throughout the length of the pusher assembly.The braided shaft was exposed.Conclusions: evaluation of the returned smart coil pusher assembly revealed the braided shaft was exposed.If the smart coil is forcefully retracted against resistance or at extreme angles, damage such as these may occur.The non-penumbra micro-catheter identified in the reported complaint was not returned for evaluation; therefore, the root cause of the resistance could not be determined.Further evaluation revealed pusher assembly kinks.These damages were likely incidental to the reported complaint and may have occurred during packaging the device for return to penumbra.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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the initial resistance.Please note that the following section was inadvertently missed on the initial mfr report and is being updated on this follow-up # 01 mfr report: 3005168196-2019-01176 1.Section d.Box 6.If implanted, give date?.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8707849
• Report Number: 3005168196-2019-01176
• Device Sequence Number: 1845026
• Product Code: HCG
• UDI-Device Identifier: 00814548015088
• UDI-Public: 00814548015088
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019
• 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: 06/21/2023
• Device Catalogue Number: 400SMTSFT0408
• Device Lot Number: F84252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005