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

Catalog Number	400PAC40
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure using pac400s, pod coils, a non-penumbra vascular plug, and a px slim delivery microcatheter (px slim).During the procedure, the physician successfully placed multiple coils and a non-penumbra vascular plug in the target location.Next, while advancing a pac400 coil through the px slim, the px slim was kinked and, consequently, the pac400 coil unintentionally detached inside the microcatheter.Therefore, the physician used a snare device was used to remove the detached pac400 coil.The procedure was considered completed.There was no report of an adverse effect to the patient.
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.
Additional Manufacturer Narrative
Please note that the following sections were inadvertently missed on the initial mfr report and are being included on this follow-up #01 mfr report:3005168196-2022-00535.1.Section h.Box 8.Usage of device.2.Section h.Box 10./11.Additional narrative and/or corrected data.

• 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: 15794510
• Report Number: 3005168196-2022-00535
• Device Sequence Number: 3010765
• Product Code: HCG
• UDI-Device Identifier: 00815948021334
• UDI-Public: 815948021334
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2022
• 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 Catalogue Number: 400PAC40
• Device Lot Number: F00002270
• 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: 10/20/2022
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2022
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005