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

Catalog Number	4002C1660
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2018
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 for endoleak type ii abdominal aortic aneurysm (aaa) using penumbra coil 400s (pc400s).During the procedure, the physician successfully placed two pc400s in the target vessel using a non-penumbra microcatheter.The physician then experienced resistance in the middle of the microcatheter and was unable to advance a pc400 through the microcatheter.Therefore, the pc400 was removed.The procedure was completed using another coil, a smart coil, and a pc400, with the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was slightly compressed on the proximal end of the pusher assembly.The pusher assembly had bends and kinks approximately 39.0 cm, 97.0 cm and 98.0 cm from the proximal end.The embolization coil was intact with the distal detachment tip (ddt) of the pusher assembly.The embolization coil had offset coil winds throughout the length of the coil.Conclusions: evaluation of the returned pc400 revealed offset coil winds and a kinked pusher assembly.The reported complaint mentioned resistance was experienced within the non-penumbra microcatheter while advancing the pc400.If the device is forcefully advancing against resistance, pusher assembly kinks and offset coil winds will likely occur.During functional testing, a demonstration coil was advanced through the returned microcatheter without issue.The root cause of the resistance could not be determined.Further evaluation revealed a proximal kink on the pusher assembly.The proximal kink was likely incidental to the reported complaint.The non-penumbra microcatheter was undamaged.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: 8151116
• Report Number: 3005168196-2018-02404
• Device Sequence Number: 1569663
• Product Code: HCG
• UDI-Device Identifier: 00814548010724
• UDI-Public: 00814548010724
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2018
• 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: Health Professional
• Device Expiration Date: 06/21/2024
• Device Catalogue Number: 4002C1660
• Device Lot Number: F70271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005