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

Catalog Number	4006C0305
Medical Device Problem Codes	Detachment Of Device Component (1104); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2018
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.This report is associated with mfr report numbers: 3005168196-2018-00415, 3005168196-2018-00417.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a bleeding aneurysm in the posterior communicating artery (pcomm), using penumbra coil 400s (pc400s) and a px slim delivery microcatheter (px slim).During the procedure, the physician successfully deployed and detached multiple pc400s in the target vessel using the px slim.While advancing and withdrawing another pc400 coil through the px slim, the physician experienced resistance and the pc400 unintentionally detached within the px slim; however, the physician was able to push and successfully place the detached pc400 in the target vessel.Next, the physician attempted to place another pc400 in the target vessel.However, while advancing and withdrawing the pc400, the physician experienced resistance again and the pc400 unintentionally detached within the px slim.When attempting to maneuver the detached pc400, the pusher assembly of the pc400 perforated the px slim.Therefore, the px slim was removed with the detached pc400 and the pusher assembly inside, as the physician aspirated through the px slim.The procedure ended at this point.It was reported that the physician needed to apply force while placing the pc400s due to the high packing density of the target location.The patient passed away due to the bleeding of the aneurysm.The physician reported that this adverse event was due to the patient¿s condition, not the penumbra products.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was detached from its pusher assembly, the sr wire was fractured, and the constraint sphere was present inside the distal detachment tip.Conclusions: evaluation of the returned px slim revealed that the pc400 was protruding through the distal shaft of the catheter and the sr wire was fractured.If the pc400 is forcefully advanced and retracted against resistance, damage such as an sr wire fracture may occur.The root cause of resistance could not be determined.If the detached embolization coil occludes the distal shaft of the px slim and subsequently, the pusher assembly is forcefully advanced, it is possible the pusher assembly may perforate through the side of the catheter shaft.Evaluation of the returned neuron max revealed no visible damage.A stainless steel mandrel was advanced through the hub of the neuron max and out of the distal tip without an issue.Evaluation of the returned handle revealed that the device was functional.The handle was functionally tested on the handle fixture for pull force and throw distance and passed for both.Penumbra coils and catheters 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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7298093
• Report Number: 3005168196-2018-00416
• Device Sequence Number: 2273956
• Product Code: HCG
• UDI-Device Identifier: 00814548011820
• UDI-Public: 00814548011820
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/30/2018

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: Physician
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 4006C0305
• Device Lot Number: F60961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR