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

Model Number	DH1
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the nose cone was detached from the handle body.Conclusions: evaluation of the returned handle revealed that the nosecone was detached from the handle body.This type of damage likely occurred during transit from penumbra to the designated location.The tabs that hold the nose cone to the handle body were not broken and the nose cone was able to be re-attached.The handle was functionally tested on a handle test fixture and was within specification.Penumbra handles are visually inspected and functionally tested by quality during incoming inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
During preparation for a coil embolization procedure, the physician opened a penumbra coil 400 detachment handle (handle) packaging and noticed that the funnel cap had broken off.The damage to the handle was noticed prior to use; therefore, the handle was not used for the procedure.The procedure was completed using a new handle.

• 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: 7958844
• Report Number: 3005168196-2018-01991
• Device Sequence Number: 11088111
• Product Code: HCG
• UDI-Device Identifier: 00814548011974
• UDI-Public: 00814548011974
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2018
• 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: 11/04/2019
• Device Model Number: DH1
• Device Catalogue Number: DH1
• Device Lot Number: F72642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 04/13/2020
• 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