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

Catalog Number	4004C0820
Medical Device Problem Codes	Out-Of-Box Failure (2311); Defective Device (2588); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact and compressed on the proximal end of the pusher assembly.The pusher assembly was fractured approximately 5.0 cm from the proximal end.The pusher assembly was kinked approximately 82.0 cm from the proximal end.The pull wire was completely retracted out of the distal detachment tip (ddt).There was no visible damage to the introducer sheath.Conclusions: evaluation of the returned device revealed that the pc400¿s pusher assembly was fractured, the pull wire was completely retracted out of the ddt, and the embolization coil was detached.Fracture of the pusher assembly typically occurs due to improper handling during removal from the packaging hoop.If the pusher assembly is forcefully handled at extreme angles during removal from the packaging hoop, it may become fractured.If the pusher assembly becomes fractured, it may allow the pull wire to retract out of the ddt, which would cause the embolization coil to detach.The embolization coil was not returned for evaluation.Further evaluation revealed that the pusher assembly was kinked.This damage was likely incidental and may have occurred while packaging the device for return.Further evaluation of the pc400 revealed that the pet lock was compressed on the proximal end of the pusher assembly.This type of damage likely occurred from forceful handling during preparation.There was no visible damage to the introducer sheath, and the friction lock seated properly on the pusher assembly mid-joint.The root cause of the pc400 being out of its introducer sheath upon removal from its packaging hoop could not be determined.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.
Event or Problem Description
During preparation for a coil embolization procedure, the physician noticed that approximately half of a penumbra coil 400 (pc400) was already out of its introducer upon removal from the dispenser hoop.While attempting to re-sheath the pc400, the physician experienced resistance and was unable to re-sheath the coil.The defective pc400 was found prior to use and therefore, was not used for the procedure.The procedure was completed using six new pc400's.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6159089
• Report Number: 3005168196-2016-01791
• Device Sequence Number: 10995074
• Product Code: HCG
• UDI-Device Identifier: 00814548010922
• UDI-Public: 00814548010922
• 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): 11/10/2016

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: 09/17/2024
• Device Catalogue Number: 4004C0820
• Device Lot Number: F71656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2016
• Initial Report FDA Received Date: 12/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1