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

Catalog Number	4006C0306
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2019
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: 3005168196-2019-00785.
Event or Problem Description
The patient was undergoing a coil embolization procedure in inferior mesenteric artery (ima) using penumbra coil 400s (pc400s) and a penumbra coil detachment handle (handle).During the procedure, the physician successfully placed a pc400 in the target location using a non-penumbra microcatheter.The physician then was unable to detach a pc400 in the target location using the handle, despite the proximal detachment marker being separated.The physician then was unable to remove the proximal end of the pusher assembly from the handle.Therefore, the pc400 and the handle were removed.The procedure was completed using a new pc400 and a new handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was separated on the proximal end of the pusher assembly and the pull tube was fully retracted out of the hypotube.The pusher assembly was bent along its length.The pull wire was retracted out of distal detachment tip (ddt) but embolization coil was still attached with the distal tip of the pusher assembly.The embolization coil had offset coil winds.Introducer sheath was not returned with the device.Conclusions: evaluation of the returned pc400 confirmed the pet lock was separated, the pull wire was retracted from the ddt but the embolization coil was still attached with the ddt.During the functional testing, the embolization coil was manually detached from the ddt by pulling on the embolization coil.A foreign material was found inside the ddt.The origin of the foreign material is unknown but likely contributed to the inability for the embolization coil to detach from the pusher assembly.Further investigation revealed bends were present along the pusher assembly.These damages may have been a result of removing the pusher assembly from the handle or during packaging for return to penumbra.Evaluation of the returned handle revealed a damaged nosecone.This supports the reported complaint that the pusher was stuck within the handle.If the pusher assembly hypotube was forcefully inserted into the nosecone of the handle, damage such as this may occur.During functional testing, the returned handle was tested with a handle test fixture and performed within specification but the handle was difficult to remove from the test fixture.Penumbra coils and handles are 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: 3005168196-2019-00785.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8547563
• Report Number: 3005168196-2019-00784
• Device Sequence Number: 13545007
• Product Code: HCG
• UDI-Device Identifier: 00814548011837
• UDI-Public: 00814548011837
• 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): 03/26/2019
• 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: 10/25/2024
• Device Catalogue Number: 4006C0306
• Device Lot Number: F72506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Date Report Sent to FDA: 01/01/2005