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

Catalog Number	4004C0306
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	02/09/2017
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.This report is associated with mfr report numbers: 3005168196-2017-00340, 3005168196-2017-00342, 3005168196-2017-00343, 3005168196-2017-00344, 3005168196-2017-00345, 3005168196-2017-00346.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a cavernous carotid fistula using penumbra coils 400 (pc400¿s) and px slim delivery microcatheters (px slim).During the procedure, while attempting to advance the initial pc400s through a px slim without a rotating hemostasis valve (rhv) and continuous flush, the physician experienced resistance and the coils would not advance through the px slim.Therefore, the px slim and pc400s were removed.The physician then opened a new px slim and attempted to advance new pc400s; however, resistance was encountered again and the pc400s would not advance through the new px slim.Therefore, the pc400s were removed.It was reported that after connecting the px slim with a rhv, a flush line and holding the hub of the px slim straight, the procedure was completed using additional pc400s and the same px slim.There was no report of an adverse effect to 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: 6395027
• Report Number: 3005168196-2017-00341
• Device Sequence Number: 31183
• Product Code: HCG
• UDI-Device Identifier: 00814548010816
• UDI-Public: 00814548010816
• 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): 02/09/2017

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: 08/31/2022
• Device Catalogue Number: 4004C0306
• Device Lot Number: F60529
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2017
• Initial Report FDA Received Date: 03/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR