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

Model Number	4002C1557
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using a penumbra coil 400 (pc400) and a px slim delivery microcatheter (px slim).During the procedure, the physician advanced a pc400 through a px slim.However, it was noticed under fluoroscopy that the pc400 did not exist through the distal tip of the px slim.Therefore, the physician removed the pc400 and re-sheathed it.Afterwards, on the back table, the physician attempted to advance the pc400 but only the pusher assembly of the pc400 was found.The procedure was completed using another pc400.There was no report of adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pc400 revealed that the pull wire was advanced distal to the pusher assembly ddt.If the device is forcefully advanced against resistance, damage such as this may occur.This damage likely contributed to the embolization coil to detach from the pusher assembly during the procedure.The detached embolization coil was not returned for evaluation.Penumbra coils are visually 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.H3 other text: placeholder.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11935420
• Report Number: 3005168196-2021-01245
• Device Sequence Number: 16984887
• Product Code: HCG
• UDI-Device Identifier: 00814548010700
• UDI-Public: 00814548010700
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• PMA/510(K) Number: K170852
• 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): 05/10/2021
• 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: 06/19/2025
• Device Model Number: 4002C1557
• Device Catalogue Number: 4002C1557
• Device Lot Number: C24336
• 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: 05/10/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Date Report Sent to FDA: 01/01/2005