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

Model Number	DH1
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 to treat a para-ophthalmic giant intracranial aneurysm (gia) using penumbra coil 400s (pc400), a penumbra coil 400 detachment handle (handle), a neuron max 6f 088 long sheath (neuron max), and a non-penumbra microcatheter.During the procedure, the physician placed and detached three pc400s into the target location using the handle.The physician then placed and detached a fourth pc400 in the aneurysm using the handle; however, the pusher assembly of the pc400 became jammed inside the handle and the physician was unable to remove it.Therefore, the handle was no longer used.The procedure was completed using an additional pc400 and a pod detachment handle (handle).There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pusher assembly was fractured on its proximal end and was stuck inside the handle.The nose cone was removed from the handle body, and it was observed that the pusher assembly was further into the handle; therefore, the handle body was opened.The pull wire and hypotube was within the handle body.The distal fractured segments of the pusher assembly were measured to be approximately 37.0 cm and 131.5 cm.The pusher assembly had kinks throughout its length.Conclusions: evaluation of the returned handle confirmed that a pusher assembly was stuck within the handle and revealed that the pusher assembly was fractured.The nose cone was removed, and it was observed that the pull wire and pusher assembly was further inside the handle body.If the pusher assembly is forcefully advanced into the handle, or if the handle is repeatedly actuated while the pusher assembly is inserted, damage such as this may occur.Further evaluation revealed that the pusher assembly had an additional fracture and was kinked in multiple locations.This damage was likely incidental to the reported complaint and may have occurred after removal from the procedure.Penumbra handles are 100% 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: 10854240
• Report Number: 3005168196-2020-02020
• Device Sequence Number: 2419473
• Product Code: HCG
• UDI-Device Identifier: 00814548011974
• UDI-Public: 00814548011974
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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): 10/22/2020
• 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: 01/31/2021
• Device Model Number: DH1
• Device Catalogue Number: DH1
• Device Lot Number: F81728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Date Report Sent to FDA: 01/01/2005