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

Catalog Number	4004C0615
Medical Device Problem Codes	Positioning Failure (1158); Physical Resistance (2578); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please note that the following device code also applies to this complaint: (b)(4).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 proper hepatic artery using penumbra coil 400''s (pc400's).The physician confirmed that the patient's anatomy was not tortuous and that there was no excessively high angulation.During the procedure, the physician initially deployed and detached two pc400's in the left gastric artery.The physician then placed another manufacturer's balloon catheter in the distal portion of the proper hepatic artery.Next, a px slim delivery microcatheter (px slim) was advanced towards the target vessel and a pc400 was then deployed and detached.While attempting to advance a new pc400 through the px slim, the physician encountered resistance.After the coil began taking shape, the physician felt resistance and decided to retract the coil.While attempting to retract the pc400, the physician also encountered resistance.Therefore, the px slim containing the coil was removed from the patient.The physician then flushed the px slim and successfully completed the procedure using a new pc400 and the same px slim.It should be noted that the physician used a rotating hemostasis valve (rhv) and maintained a continuous flush throughout the procedure.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: 6277072
• Report Number: 3005168196-2017-00105
• Device Sequence Number: 1154794
• Product Code: HCG
• UDI-Device Identifier: 00814548010885
• UDI-Public: 00814548010885
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2016

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: 04/24/2024
• Device Catalogue Number: 4004C0615
• Device Lot Number: F69103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2016
• Initial Report FDA Received Date: 01/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1