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

Model Number	4002C1557
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
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 splenic artery using a penumbra coil 400 (pc400) and a non-penumbra microcatheter.During the procedure, while the physician advanced a pc400 into the microcatheter, the physician experienced resistance.Subsequently, part of the pc400 became stuck in the microcatheter and would not advance further.Therefore, the physician decided to remove the pc400 and noticed upon removal that there was a knot in the middle of the pc400.The procedure was completed using additional pc400s and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pc400 embolization coil confirmed a knot.Based on the reported complaint, the root cause of this damage could not be determined.Further evaluation revealed offset coil winds throughout the length of the embolization coil.This damage was likely incidental to the reported complaint and may have occurred during manipulation against resistance, or during packaging of the device for return to penumbra.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: 11547807
• Report Number: 3005168196-2021-00552
• Device Sequence Number: 19816351
• Product Code: HCG
• UDI-Device Identifier: 00814548010700
• UDI-Public: 00814548010700
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2021
• 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 Expiration Date: 05/10/2022
• Device Model Number: 4002C1557
• Device Catalogue Number: 4002C1557
• Device Lot Number: C10851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/21/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005