MAUDE Adverse Event Report: PENUMBRA, INC. PAC400 COIL; HCG, KRD

Model Number	400PAC60
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing coil embolization procedure in the aortic arch using a penumbra coil 400 (pc400) and a px slim delivery microcatheter (px slim).During the procedure, while advancing a pc400 through the px slim, the physician experienced resistance.Subsequently, the pc400 would not fully advance out of its introducer sheath.Therefore, the pc400 was removed.The procedure was completed using a new pc400 and the same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:.1.Section b.Box 5.Describe event or problem.2.Section g.Box 5.510(k) #.3.Section h.Box 8.Usage of device h3 other text : placeholder.
Event or Problem Description
The patient was undergoing coil embolization procedure in the aortic arch using a pac400 and a px slim delivery microcatheter (px slim).During the procedure, while advancing a pac400 through the px slim, the physician experienced resistance.Subsequently, the pac400 would not fully advance out of its introducer sheath.Therefore, the pac400 was removed.The procedure was completed using a new pac400 and the same px slim.There was no report of an adverse effect to the patient.

• Brand Name: PAC400 COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12005240
• Report Number: 3005168196-2021-01340
• Device Sequence Number: 14305556
• Product Code: HCG
• UDI-Device Identifier: 00815948021358
• UDI-Public: 00815948021358
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2022
• 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: 400PAC60
• Device Catalogue Number: 400PAC60
• Device Lot Number: C24431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005