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

Catalog Number	4002C0925
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2016
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400s (pc400).During the procedure, the physician experienced resistance while advancing a pc400 through a px slim delivery microcatheter (px slim), and the pc400 became stuck.Therefore, the physician removed the px slim from the patient and successfully removed the pc400 from it.The procedure was completed using the same px slim and new pc400s.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: the pet lock is intact on the proximal end of the pusher.The pusher assembly was kinked approximately 30.0 and 34.0 cm from the proximal end of the pusher assembly.The embolization coil was intact with the pusher assembly.The distal tip of the embolization coil showed offset coil winds and kinks in multiple locations.The maximum outer diameter (od) was measured and the pc400 was within product specification.Conclusions: evaluation of the pc400 revealed the embolization coil was compressed and kinked in multiple locations.The embolization coil was unable to be fully cycled in and out of its introducer sheath.This damage likely occurred as a result of repeated forceful attempts to advance or withdraw the pc400.Further evaluation revealed kinks in the pusher assembly.This damage was likely incidental and may have occurred during packaging for return to penumbra facilities.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: 6047676
• Report Number: 3005168196-2016-01495
• Device Sequence Number: 888801
• Product Code: HCG
• UDI-Device Identifier: 00814548010571
• UDI-Public: 00814548010571
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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
• Report Date (Section B): 09/22/2016

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: 09/09/2023
• Device Catalogue Number: 4002C0925
• Device Lot Number: F65644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2016
• Supplement Report FDA Received Date: 06/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR