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

Catalog Number	4002C1450
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	06/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2017-01177.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the thoracic artery using penumbra coil 400''s (pc400¿s).During the procedure, the physician deployed and detached an initial pc400 into the target vessel using another manufacturer's microcatheter.After introducing the introducer sheath of a new pc400 through the hub of the microcatheter, the physician encountered resistance and was unable to advance the coil.Therefore, the physician removed the pc400 and was able to advance the coil out of its introducer sheath.While attempting to re-advance the pc400 into the microcatheter, resistance was encountered again and the pc400 would not advance.Therefore, the pc400 was removed and a new pc400 was opened and placed into the target vessel without any issues.While attempting to advance a new pc400 into the microcatheter, the physician met resistance and was unable to advance the coil into the microcatheter.Therefore, the pc400 was removed and the procedure was completed using additional coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the penumbra coil 400 (pc400) embolization coil had multiple offset coil winds and coagulated blood along its length.The pusher assembly had a kink approximately 6.0 cm from the proximal end and the pet lock was intact.The embolization coil was detached from the pusher assembly.Conclusions: evaluation of the returned pc400's revealed that their pusher assemblies were kinked.These pusher assembly kinks are likely a result of forcefully advancing the ruby coil against resistance.If a rotating hemostasis valve (rhv) is not used, the introducer sheath may not align properly within the microcatheter hub.If the introducer sheath is not properly aligned when advancing the embolization coil, the coil may begin to take shape in the hub resulting in strong resistance and the inability to advance the coil into the microcatheter.Forceful attempts to advance against this resistance can result in the observed kinks and offset coil winds.The coagulated blood was likely present due to the lack of using a rotating hemostasis valve (rhv) and continuous flush during the procedure.Further evaluation revealed that both coils were detached from their pusher assemblies and both pet locks remained intact.This is likely due to the polymer section of the pusher assembly stretching enough such that the pull wire retracts proximally from the ddt allowing the coil to detach.Since both pc400s were reported as removed from the procedure with no report of detachment, these detachments were likely incidental, and likely occurred after removal of the pc400 from the procedure.The non-penumbra microcatheter mentioned in the complaint and embolization coil for the first pc400 were 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: 6715924
• Report Number: 3005168196-2017-01178
• Device Sequence Number: 10955380
• Product Code: HCG
• UDI-Device Identifier: 00814548010687
• UDI-Public: 00814548010687
• 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,Followup
• Report Date (Section B): 06/15/2017

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: 09/09/2023
• Device Catalogue Number: 4002C1450
• Device Lot Number: F65652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Initial Date Received by Manufacturer: 06/15/2017
• Supplement Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 07/14/2017
• Supplement Report FDA Received Date: 08/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1