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

Catalog Number	4006C0304
Medical Device Problem Codes	Detachment Of Device Component (1104); Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra coil 400 coil (pc400 coil) pet lock was broken, and the pull wire was retracted.The pusher assembly was bent in multiple locations throughout its length.The embolization coil was inside the px slim and detached from the distal detachment tip (ddt).The embolization coil was flushed out of the px slim by a penumbra investigator, and the proximal constraint sphere was observed to be intact on the proximal end of the embolization coil.Conclusions: evaluation of the returned device revealed that the pc400 coil pusher assembly was bent in multiple locations.This type of damage may occur if the pc400 is forcefully manipulated against resistance.Further evaluation revealed the pet lock on the proximal end of the pusher assembly was broken and the pull wire was retracted, indicating a pull force was successfully applied to the proximal end of the pull wire.The sma that was navigated by the pc400 coil is tortuous, even in normal anatomy.The tortuosity in these vessels, along with the bends observed in the pusher assembly, could have prevented the embolization coil from detaching.Extreme tortuosity along the majority length of the pusher can cause a build-up of friction between the pull wire and the inner pusher tube, overcoming the force that the handle is able to apply.Withdrawing the pc400 will alleviate some of the friction, and the tension in the pull wire may cause the coil to unintentionally detach.Evaluation of the returned handles and px slim revealed they were functional and had no visible damage.Penumbra coils and handles are 100% functionally evaluated during in-process inspection, and penumbra catheters are 100% visually evaluated during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the superior mesenteric artery (sma) using penumbra coil 400 coils (pc400 coils).During the procedure, the physician was unable to reach the target vessel and deliver the pc400 coils, therefore, the physician deployed and detached two pc400 coils into a branch vessel located before the aneurysm using a px slim delivery microcatheter (px slim) and a penumbra coil 400 detachment handle (handle).Next, the physician deployed a third pc400 coil into the branch vessel; however, the pc400 coil was unable to detach using the handle.The physician then attempted to use a new handle to detach the pc400 coil but was still unsuccessful.Therefore, the physician decided to remove the pc400 coil from the patient.While the pc400 coil was being retracted, it unintentionally detached inside the px slim.The physician removed the px slim containing the pc400 coil from the patient and ended the procedure at this point since angiography revealed occlusion of the aneurysm.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report:3005168196-2016-00308.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5496473
• Report Number: 3005168196-2016-00308
• Device Sequence Number: 445216
• Product Code: HCG
• UDI-Device Identifier: 00814548011813
• UDI-Public: 00814548011813
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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): 02/15/2016
• 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: Physician
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 4006C0304
• Device Lot Number: F43689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2016
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/14/2016
• Supplement Date Received by Manufacturer: 02/15/2016
• Initial Report FDA Received Date: 03/11/2016
• Supplement Report FDA Received Date: 12/28/2018
• 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