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

Catalog Number	400SMTXSFT3H06
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.
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 placed a non-penumbra coil in the target vessel using a non-penumbra microcatheter.While placing a smart coil in the target vessel, approximately five millimeters of the proximal end of the smart coil stopped taking its intended shape; therefore, it was removed.The physician then successfully placed two other coils and a smart coil in the ica.While attempting to advance a non-penumbra coil into the microcatheter, the physician experienced resistance near the hub of the microcatheter.The physician then pushed the guidewire into the microcatheter with some resistance and the guidewire stopped approximately five centimeters from the distal tip of the microcatheter.Therefore, the physician removed the microcatheter and the guidewire altogether from the patient¿s body.Upon flushing the microcatheter, a red-colored foreign object that looked like thrombus came out of the microcatheter.The procedure was completed using another microcatheter and coils.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7631727
• Report Number: 3005168196-2018-01252
• Device Sequence Number: 19453410
• Product Code: HCG
• UDI-Device Identifier: 00814548017112
• UDI-Public: 00814548017112
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 05/25/2018

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: Physician
• Device Expiration Date: 05/08/2022
• Device Catalogue Number: 400SMTXSFT3H06
• Device Lot Number: F79964
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1