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

Catalog Number	4002C0830
Medical Device Problem Codes	Detachment Of Device Component (1104); Positioning Failure (1158); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2016
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 in the internal iliac artery (iia) using penumbra coil 400's (pc400's).During the procedure, the physician deployed and detached seven pc400''s into the iia using a px slim delivery microcatheter (px slim) without an issue.The physician then attempted to deploy the eighth pc400 into the target vessel; however, the coil did not take its intended shape.Therefore, the physician manipulated the px slim in order to retract and advance the pc400 several times.After manipulating the devices for some time, the physician did not encounter resistance but noticed that the pc400 had unintentionally detached.Because more than half of the coil was left inside the px slim, the physician carefully removed the px slim containing the detached pc400 and completed the procedure using the same px slim and a new pc400.It should be noted that the physician used a rotating hemostasis valve (rhv) and flushed the px slim between each coil used during 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: 6257521
• Report Number: 3005168196-2017-00070
• Device Sequence Number: 13668572
• Product Code: HCG
• UDI-Device Identifier: 00814548010564
• UDI-Public: 00814548010564
• 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): 12/19/2016

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: 05/07/2024
• Device Catalogue Number: 4002C0830
• Device Lot Number: F69248
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2016
• Initial Report FDA Received Date: 01/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR