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

Model Number	4006C0406
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-00033.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) 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 and subsequently, the pc400 became stuck.The physician then decided to retract the pc400.However, during retraction, the physician noticed that the pc400 had unintentionally detached inside the px slim.Therefore, the px slim containing the detached pc400 was removed.The procedure was completed using other coils and another microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pc400 revealed that the embolization coil sr wire was fractured.This type of damage typically occurs due to forceful retraction the device against resistance.The px slim used in the procedure was returned for evaluation and no damage was observed on the px slim.Therefore, the root cause of the resistance experienced during the procedure was unable to be determined.The offset coil winds on the embolization coil were likely incidental to the complaint.Evaluation of the returned px slim revealed an undamaged and functional device.During functional testing, a demonstration pc400 was able to advance through the returned px slim without issue.Penumbra coils and catheters are inspected during in-process inspection and during quality inspection after manufacturing.This report is associated with mfr report number: 3005168196-2021-00033.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11134467
• Report Number: 3005168196-2021-00032
• Device Sequence Number: 11574960
• Product Code: HCG
• UDI-Device Identifier: 00814548011899
• UDI-Public: 00814548011899
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• 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): 12/08/2020
• 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: 03/02/2024
• Device Model Number: 4006C0406
• Device Catalogue Number: 4006C0406
• Device Lot Number: F68221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 02/18/2021
• 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