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

Model Number	400SMTXSFT0410
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2019
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.This report is associated with mfr report number: 3005168196-2019-02322.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the cerebral artery using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), a non-penumbra guidewire, and a non-penumbra microcatheter.During the procedure, the physician implanted five smart coils into the target vessel without issue using the handle.However, the sixth smart coil did not detach from its pusher assembly until the second attempt using the handle.The physician continued the procedure using another smart coil and encountered resistance during advancement through the microcatheter.It was then reported that the smart coil became stuck and neither the smart coil nor the guidewire could advance past the same position within the microcatheter.The devices were then removed from the patient.Upon removal, a white powdery substance came out of the microcatheter.Therefore, the microcatheter was no longer used in the procedure.The procedure was completed using another non-penumbra microcatheter, the same smart coil, two additional smart coils, the same handle and a non-penumbra coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the smart coil pusher assembly was returned wrapped on itself with bends along it's length.Conclusions: evaluation of the returned smart coil pusher assembly revealed it was wrapped around themselves resulting in bend damage throughout each returned device.This was likely incidental to the reported complaint.There was no functional allegation against any of the returned pusher assemblies.Evaluation of the pusher assembly revealed damage to the lamination on the distal portion of the pusher assembly.It was reported this smart coil required two attempts to be detached.The damage to the braided shaft of the pusher assembly may contribute to difficulty detaching.The root cause of the pusher assembly damage 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: 9475187
• Report Number: 3005168196-2019-02321
• Device Sequence Number: 2751345
• Product Code: HCG
• UDI-Device Identifier: 00814548015408
• UDI-Public: 00814548015408
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2019
• 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: 07/01/2023
• Device Model Number: 400SMTXSFT0410
• Device Catalogue Number: 400SMTXSFT0410
• Device Lot Number: F84421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 09/01/2020
• 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