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

Model Number	4006C0406-A
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2021
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 internal carotid artery (ica) and external carotid artery (eca) using penumbra coils 400 (pc400s) and a px slim delivery microcatheter (px slim).During the procedure, the physician implanted three pod coils in the target vessel.Subsequently, while attempting to insert the fourth coil, a pc400, into the px slim, the physician experienced resistance.Therefore, the pc400 was removed.The procedure was completed using penumbra coils 400 (pc400s), pod coils, and the same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pc400 revealed a functional device.Further evaluation revealed pusher assembly bends and kinks.If the device is forcefully advanced against resistance or is otherwise mishandled at extreme angles during use, damage such as this may occur.During functional testing, the pc400 was advanced through its introducer sheath and a demonstration lantern with resistance due to the pusher assembly kinks.Some of the bends and kinks may be incidental to the reported complaint and may have occurred during packaging of the device for return to penumbra.The root cause of the initial resistance during the procedure 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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11254281
• Report Number: 3005168196-2021-00175
• Device Sequence Number: 14144939
• Product Code: HCG
• UDI-Device Identifier: 00814548018218
• UDI-Public: 00814548018218
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K170852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021
• 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 Model Number: 4006C0406-A
• Device Catalogue Number: 4006C0406
• Device Lot Number: F90367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 03/09/2021
• 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