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

Catalog Number	DH1
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/26/2019
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
During preparation for a medical procedure, the physician was testing the penumbra coil 400 detachment handle (handle) and reported that the trigger was slow and did not make the ''popping'' sound.The issue with the handle was found prior to use and, therefore, the handle was not used in the procedure.Subsequently, the physician lost access to the target vessel and the procedure was ended.
Additional Manufacturer Narrative
Results: the penumbra coil 400 detachment handle (handle) was undamaged.Conclusions: evaluation of the returned handle revealed a fully functional device.During the functional testing, the handle was tested on a handle test fixture and tested within specification.The handle was found to make a dull click instead of an expected ¿popping sound.¿ however, this did not affect the device functionality.Penumbra handles are visually inspected and functionally tested during incoming quality inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA COIL 400 DETACHMENT HANDLE
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8459466
• Report Number: 3005168196-2019-00560
• Device Sequence Number: 2746424
• Product Code: HCG
• UDI-Device Identifier: 00814548011974
• UDI-Public: 00814548011974
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2019
• 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: 07/08/2021
• Device Catalogue Number: DH1
• Device Lot Number: F84534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 05/08/2019
• 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