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

Catalog Number	400SMTXSFT0406
Medical Device Problem Code	Material Twisted/Bent (2981)
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, while advancing the smart coil through a non-penumbra microcatheter, the smart coil pusher assembly became bent and, therefore, it 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 "united arab emirates" was incorrectly reported on the initial mfr report and is being included on this follow-up #02 mfr report: 3005168196-2019-02082.1.Section e.Box 1.Country: it should be "united states.".
Additional Manufacturer Narrative
Results: the pet lock was separated on the proximal end of the penumbra smart coil (smart coil) pusher assembly.The pusher assembly was twisted together.The embolization coil was detached from the pusher assembly.The embolization coil had offset coil winds.Conclusions: evaluation of the returned smart coil revealed the pusher assembly was twisted together, the pet lock was separated on the proximal end of the pusher assembly and the embolization coil was detached and had offset coil winds.These damages were not mentioned in the complaint and were likely incidental.Based on the return condition of the smart coil, the root cause of the reported complaint could not 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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9304966
• Report Number: 3005168196-2019-02082
• Device Sequence Number: 19263437
• Product Code: HCG
• UDI-Device Identifier: 00814548015385
• UDI-Public: 00814548015385
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: TC
• 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: 03/19/2024
• Device Catalogue Number: 400SMTXSFT0406
• Device Lot Number: F89184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• 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: 11/11/2019; 01/14/2005
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 11/13/2019; 12/13/2019
• 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