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

Catalog Number	4002C1040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2019
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using penumbra coil 400s (pc400s).During the procedure, the physician introduced a non-penumbra guide catheter from the femoral artery and placed a px slim delivery microcatheter (px slim) in the target vessel.The physician then advanced a pc400 in the target vessel and formed four loops.While attempting to pull the pc400 in order to reposition it, the pc400 unintentionally detached.Therefore, the physician removed the px slim and pc400 pusher assembly, then removed the guide catheter and the detached coil.The procedure was completed using a new guide catheter, the same px slim and five additional pc400s.There was no report of an adverse effect to the patient.
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 and the distal detachment tip (ddt) was fractured off the distal tip of the pusher assembly.Conclusions: evaluation of the returned pc400 revealed that the ddt was fractured off the distal tip of its pusher assembly.If the device is forcefully retracted against resistance, damage such as the ddt fracturing of the pusher assembly may occur.The root cause of resistance could not be determined.While functionally testing the returned guide catheter, a mandrel was advanced though the guide catheter to remove the returned embolization coil.Then a demonstration px slim was advanced through the guide catheter.A demonstration pc400 was then advanced through the hub of the px slim and out of the distal tip without an issue.After removing the demonstration pc400 and px slim, the demonstration pc400 was attempted to be advanced through the non-penumbra guide catheter.As expected, due to the increased lumen of the guide catheter, the pc400 became stuck within the catheter and the coil could not be advance or retracted from the catheter.The px slim identified in the complaint was not returned to penumbra for evaluation.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: 8344531
• Report Number: 3005168196-2019-00270
• Device Sequence Number: 19107102
• Product Code: HCG
• UDI-Device Identifier: 00814548010601
• UDI-Public: 00814548010601
• 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): 01/16/2019
• 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: 03/07/2025
• Device Catalogue Number: 4002C1040
• Device Lot Number: F74858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 05/07/2019
• 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