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

Model Number	4002C1040
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2020
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 mid-basilar artery aneurysm using penumbra coil 400s (pc400s), a px slim delivery microcatheter (px slim) and a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician successfully implanted two pc400s in the aneurysm using the px slim and neuron max.The physician then attempted to place the third pc400 into the aneurysm but was unsuccessful; therefore, the physician reduced the slack of the px slim and attempted again to place the pc400 but was also unsuccessful; therefore, the pc400 was removed.Upon removal of the pc400, it was noticed that there was a lot of clot on the pc400; therefore, the pc400 was rinsed.The physician then attempted to advance the pc400 through the px slim but the px slim got kicked out of placed.The px slim was then secured back into placed and the physician attempted again to place the pc400 into the aneurysm but was unsuccessful.Therefore, the pc400 was removed.The procedure was completed using a new pc400 and the same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 3005168196-2020-00467.Please note that the following section is being updated on this follow-up #01 mfr report: 3005168196-2020-00467.
Additional Manufacturer Narrative
Results: the introducer sheath was loaded backwards onto the pc400.The pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with the pusher assembly distal detachment tip (ddt).Offset coil winds were present along the embolization coil.Conclusions: evaluation of the returned pc400 revealed offset coil winds on the embolization coil and that the introducer sheath was loaded backwards onto the device.The inner diameter (id) of the introducer sheath friction lock is smaller than the rest of the introducer sheath, which allows it to seat properly onto the pusher assembly mid-joint.If the embolization coil is attempted to be advanced through the introducer sheath friction lock, resistance may be experienced, and the coil may not advance completely out of the introducer sheath.During functional testing, the pc400 was retracted out of its introducer sheath and re-sheathed properly.The pc400 was then able to advance through its introducer sheath and a demonstration lantern without resistance due to the offset coil winds.Penumbra coils are 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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9907866
• Report Number: 3005168196-2020-00467
• Device Sequence Number: 2814381
• Product Code: HCG
• UDI-Device Identifier: 00814548010601
• UDI-Public: 00814548010601
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2020
• 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: 08/13/2026
• Device Model Number: 4002C1040
• Device Catalogue Number: 4002C1040
• Device Lot Number: F85248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 01/14/2005; 01/22/2021
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 04/02/2020; 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Date Report Sent to FDA: 01/01/2005