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

Catalog Number	4004C0412
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2018
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 left internal carotid artery (ica) using penumbra coil 400s (pc400s).During the procedure, while attempting to advance a pc400 into a px slim delivery microcatheter (px slim), the pc400 would not advance past the proximal end of the px slim; therefore, the pc400 was removed.The procedure was completed using a new pc400 and the same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact at the proximal end of the pusher assembly.The pusher assembly had a bend and kink approximately 5.0 cm and 57.0 cm from the proximal end.The stretch resistant (sr) wire within the embolization coil was fractured and the proximal constraint sphere was within the pusher assembly distal detachment tip (ddt).Conclusions: evaluation of the returned pc400 revealed a kinked pusher assembly.If the device is forcefully advanced against resistance, damage such as a kink may occur.The px slim used in the procedure was not returned for evaluation; therefore, the root cause of this resistance could not be determined.Further evaluation revealed a detached embolization coil due to sr wire fracture.This damage was not identified in the reported complaint and was likely incidental to the reported complaint.Penumbra coils 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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8189953
• Report Number: 3005168196-2018-02489
• Device Sequence Number: 16804445
• Product Code: HCG
• UDI-Device Identifier: 00814548010847
• UDI-Public: 00814548010847
• Combination Product (Y/N): Y
• 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): 11/23/2018
• 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: 07/01/2026
• Device Catalogue Number: 4004C0412
• Device Lot Number: F84454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/23/2018
• Supplement Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 12/21/2018
• 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: 66 YR
• Date Report Sent to FDA: 01/01/2005