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

Catalog Number	4004C1030
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2018
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.
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 was advancing the first pc400 coil into the target vessel using a non-penumbra microcatheter when it unintentionally detached inside the microcatheter.Therefore, the pc400 and microcatheter were removed.The procedure was completed using a new microcatheter and a new pc400.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pc400 was detached from its pusher assembly and stuck inside the non-penumbra microcatheter.The non-penumbra microcatheter was ovalized approximately 15.0 cm from the hub.Conclusions: evaluation of the returned pc400 revealed that the embolization coil was detached inside the non-penumbra microcatheter.It is possible the pusher assembly became fractured while advancing, allowing the embolization coil to detach and become stuck within the microcatheter.There was an ovalization on the returned microcatheter that may have contributed to the pusher assembly becoming fractured while advancing.A pusher assembly fractured further supports why the embolization coil and proximal constraint sphere were present inside the returned microcatheter.During attempts to remove the coil from the microcatheter resistance was encountered and the sr wire may have fractured.During functional testing, the microcatheter burst due to pressure created when attempting to push a mandrel through the occluded device.This damage was done by the penumbra investigator and was incidental to the reported failure.The pusher assembly was not returned for evaluation; therefore, the root cause of the unintentional detachment could not be determined.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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8148668
• Report Number: 3005168196-2018-02402
• Device Sequence Number: 11269424
• Product Code: HCG
• UDI-Device Identifier: 00814548010977
• UDI-Public: 00814548010977
• 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): 11/12/2018
• 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: 05/15/2020
• Device Catalogue Number: 4004C1030
• Device Lot Number: F63993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005