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

Catalog Number	4006C0203
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	11/17/2017
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 in the anterior communicating artery (acom) using penumbra coil 400 (pc400's).During the procedure, while attempting to advance a pc400 out of its introducer sheath and into the hub of a px slim delivery microcatheter (px slim), the physician encountered resistance and was unable to advance the coil out of its introducer sheath.Therefore, the introducer sheath containing the pc400 was removed and the procedure was completed using new pc400's and the same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the penumbra coil 400 (pc400) pusher assembly was retracted such that the introducer sheath friction lock was stuck on the pusher assembly mid-joint.The pusher assembly was kinked just proximal to the proximal end of the introducer sheath.Conclusions: evaluation of the returned pc400 revealed that the pusher assembly had been retracted too far such that the pusher assembly mid-joint was stuck at the introducer sheath friction lock.The friction lock inner diameter (id) is smaller than the rest of the introducer sheath, which allows the introducer sheath to properly seat on the pusher assembly mid-joint.If the pusher assembly mid-joint is forcefully withdrawn beyond the introducer sheath friction lock, it is likely that resistance will be experienced upon attempting to advance the coil.The pusher assembly was unable to be advanced through the introducer sheath during functional testing.Further evaluation revealed a kink on the pusher assembly just proximal to the introducer sheath.This damage was likely a result of forcefully advancing the pusher against the resistance of the pusher mid-joint and introducer sheath friction lock.The px slim referred to 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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7110385
• Report Number: 3005168196-2017-02212
• Device Sequence Number: 16160432
• Product Code: HCG
• UDI-Device Identifier: 00814548011776
• UDI-Public: 00814548011776
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2017

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: 03/01/2025
• Device Catalogue Number: 4006C0203
• Device Lot Number: F74737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/17/2017
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR