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

Model Number	4002C1245
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2020
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 right internal carotid artery (ica) using penumbra coil 400 (pc400s) and a px slim delivery microcatheter (px slim).It was noted that the patient anatomy was tortuous.During the procedure, the physician experienced resistance while advancing the pc400 through the px slim; therefore, it 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 on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 68.0 cm, 112.0 cm, 114.0 cm and 115.0 cm from the proximal end.The pull wire was within its capture feature inside the distal detachment tip (ddt) and slightly advanced distal to its initial position.The embolization coil was detached from the pusher assembly and had offset coil winds on its proximal end.The proximal constraint sphere was intact with the embolization coil.Conclusions: evaluation of the returned pc400 revealed pusher assembly kinks.If the device is forcefully advance against resistance, damage such as pusher assembly kinks may occur.The pxslim used in the procedure was not returned for evaluation; therefore, the root cause of the resistance could not be determined.Further evaluation revealed that the embolization coil was detached from its pusher assembly and had offset coil winds at its proximal end.These damages were likely incidental to the complaint and could have occurred during retracting the device against the resistance.The additional kink observed on the pusher assembly was likely occurred during packaging the device for returned to penumbra.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: 9679684
• Report Number: 3005168196-2020-00169
• Device Sequence Number: 16761527
• Product Code: HCG
• UDI-Device Identifier: 00814548010649
• UDI-Public: 00814548010649
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• 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): 01/17/2020
• 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 Model Number: 4002C1245
• Device Catalogue Number: 4002C1245
• Device Lot Number: F86329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 04/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Date Report Sent to FDA: 01/01/2005