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

Model Number	4004C1440
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Difficult or Delayed Separation (4044)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
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 in the internal carotid artery (ica) using penumbra coils 400 (pc400s), a penumbra coil 400 detachment handle (handle), and px slim delivery microcatheter (px slim).During the procedure, the physician placed seven coils in the target vessel.The eighth coil, a pc400, was then being placed.While attempting to push the pusher assembly of the pc400, the physician felt resistance in the microcatheter despite the pc400 was properly shaped in the aneurysm.When the physician attempted to detach the pc400 using the handle, the pc400 did not detach.Subsequently, the physician recaptured the pc400 into the px slim.It was observed that the pc400 unintentionally detached in the px slim.Therefore, the px slim containing the detached pc400 was removed.The procedure was completed using two new coils and the same handle and px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pc400 revealed that the pet lock was intact on the proximal end of the pusher assembly and the pull wire was inside the ddt.If the handle is not properly seated on the proximal end of the pusher assembly during an attempt to detach the coil, the pet lock may not separate and the embolization coil will not detach.Further evaluation of the returned pc400 revealed an ovalized introducer sheath, a detached embolization coil due to a fractured sr wire, and kinks in the pusher assembly.He root cause of the ovalization in the introducer sheath could not be determined.However, this damage may have contributed to the reported resistance during the procedure.The fractured sr wire likely occurred due to forceful retraction of the device against resistance.The kinks in the pusher assembly were likely incidental to the reported complaint.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: 11085867
• Report Number: 3005168196-2020-02367
• Device Sequence Number: 11708746
• Product Code: HCG
• UDI-Device Identifier: 00814548011059
• UDI-Public: 00814548011059
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• 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): 12/01/2020
• 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 Model Number: 4004C1440
• Device Catalogue Number: 4004C1440
• Device Lot Number: F94560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 02/12/2021
• 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