MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number	4002C2260
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2016
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 using penumbra coils 400 (pc400).During the procedure, the physician experienced resistance while attempting to advance a pc400 through a px slim delivery microcatheter (px slim) and the pc400 coil was unable to advance.Therefore the physician retracted the pc400 then flushed the px slim before attempting to advance the same pc400 coil again.However, the physician experienced resistance again while advancing the pc400 coil through the px slim; therefore, the pc400 was removed.The procedure was completed using the same px slim and a new pc400.The physician reported that continuous flush was maintained and a rotating hemostasis valve was used.There was no report of an adverse effect on the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6106640
• Report Number: 3005168196-2016-01644
• Device Sequence Number: 10933161
• Product Code: HCG
• UDI-Device Identifier: 00814548010786
• UDI-Public: 00814548010786
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• 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
• Report Date (Section B): 10/20/2016

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: 01/14/2021
• Device Catalogue Number: 4002C2260
• Device Lot Number: A32461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2016
• Initial Report FDA Received Date: 11/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1