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

Model Number	4004C1235
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400s (pc400's).During the procedure, the physician experienced resistance while advancing a pc400 through a px slim delivery microcatheter (px slim); therefore, the pc400 was removed.The procedure was completed using the same px slim, nine new pc400's, and non-penumbra coils.It should be noted that the physician reported using a rotating hemostasis valve and maintaining continuous flush.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: there was no visible damage to the penumbra coil 400 (pc400).During evaluation, the stretch resistant wire (sr wire) was fractured by the penumbra investigator.The pet lock is intact on the proximal end of the pusher assembly.Conclusions: evaluation of the device revealed the pc400 was able to be advanced through a px slim and out the distal tip without issue.The root cause of this complaint could not be determined.The px slim mentioned in the complaint was not returned for evaluation.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report:3005168196-2017-00132.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6287859
• Report Number: 3005168196-2017-00132
• Device Sequence Number: 47159
• Product Code: HCG
• UDI-Device Identifier: 00814548011011
• UDI-Public: 00814548011011
• Combination Product (Y/N): Y
• Initial Reporter Country: KS
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2017
• Report Date (Section F): 01/01/2005

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: 02/03/2022
• Device Model Number: 4004C1235
• Device Catalogue Number: 4004C1235
• Device Lot Number: F41258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/03/2017
• Supplement Date Received by Manufacturer: Not provided; 01/14/2005
• Initial Report FDA Received Date: 01/30/2017
• Supplement Report FDA Received Date: 04/03/2017; 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Date Report Sent to FDA: 01/01/2005