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

Model Number	DH1
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2020
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: 1.3005168196-2020-00226.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the transverse sinus using a penumbra coil 400 detachment handle (handle) and penumbra coils 400 (pc400s).During the procedure, the physician successfully detached a pc400 in the target vessel using the handle.However, the pusher assembly of the pc400 became stuck in the handle; therefore, the handle was removed.The procedure was completed using another handle and additional pc400s.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: a pull tube with a fractured pull wire from a pusher assembly was stuck within the returned handle.The nose cone was removed from the handle body and the funnel hole was found to be damaged.The nose cone funnel hole was measured with a pin gauge and was within specification.Conclusions: evaluation of the returned handle revealed a damaged nose cone and a pull tube with a fractured pull wire was stuck within the handle.If the pc400 is forcefully inserted into the handle nose cone, and the handle manipulated at extreme angles or is repeatedly actuated, damages such as these may occur.During functional testing, the pull tube was removed from the handle, and the handle was tested with a handle test fixture and performed within specification.This indicates the funnel hole damage did not affect the functionality of the device.A demonstration pc400 was also detached with the returned handle and the pc400 pusher assembly was able to be removed from the nose cone without issue.Penumbra handles are visually inspected and functionally tested during incoming inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 1.3005168196-2020-00226.

• 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: 9729751
• Report Number: 3005168196-2020-00225
• Device Sequence Number: 2460556
• Product Code: HCG
• UDI-Device Identifier: 00814548011974
• UDI-Public: 00814548011974
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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): 01/28/2020
• 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: 08/21/2022
• Device Model Number: DH1
• Device Catalogue Number: DH1
• Device Lot Number: F92625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 02/19/2020
• 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
• Patient Age: 67 YR
• Date Report Sent to FDA: 01/01/2005