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

Catalog Number	4006U0202
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2019
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: 3005168196-2019-00858.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra coil 400s (pc400) and a penumbra coil 400 detachment handle (handle).During the procedure, the physician successfully placed pc400s in the target vessel using a px slim delivery microcatheter (px slim).After advancing a new pc400 into the vessel, the physician made multiple attempts to detach the pc400 using a handle; however, it failed to detach.Therefore, the pc400 was removed.It was reported that the physician decided to end the procedure to bring back the patient at a later date to place a non-penumbra pipeline stent; therefore, no additional coils were needed.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the proximal portion of the pet lock was missing but the pull wire was not retracted.The pusher assembly was kinked approximately 14.0, 21.0, 30.0, 64.0, 108.5, and 123.0 cm from the proximal end.The embolization coil was intact with its pusher assembly and the pull wire is within the distal detachment tip (ddt).Conclusions: evaluation of the returned pc400 revealed the embolization coil was intact with the pusher assembly and the pull wire was present within the ddt.This likely indicates the handle was not properly actuated on the proximal end of the pusher assembly.During functional testing, a demonstration handle was used to detach the embolization coil without issue.Further evaluation revealed the proximal portion of the pet lock was missing from the pusher assembly.The root cause of this could not be determined.The handle, px slim, and pc400 introducer sheath associated with the complaint were not returned for evaluation.Further evaluation revealed kinks on the pusher assembly.This damage was 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.This report is associated with mfr report number: (b)(4) 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: 8575483
• Report Number: 3005168196-2019-00859
• Device Sequence Number: 11295121
• Product Code: HCG
• UDI-Device Identifier: 00814548011356
• UDI-Public: 00814548011356
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): 04/03/2019
• 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 Catalogue Number: 4006U0202
• Device Lot Number: A32871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005