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

Model Number	4002C1660
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2020
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.This report is associated with mfr report number: 3005168196-2020-00998.
Event or Problem Description
The patient was undergoing a coil embolization in the abdominal aorta using pc400 coils and a px slim delivery microcatheter (px slim).During the procedure, while pushing a pc400 coil through the introducer sheath and into the px slim, the physician experienced resistance, and the pc400 coil stopped advancing in the px slim.Therefore, the pc400 coil and px slim were removed.The procedure was completed using a non-penumbra coil and non-penumbra microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being updated on this follow-up #01 mfr report:3005168196-2020-00997 1.Section h.Box 6.Device code 2.Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked at approximately 5.0 cm, 15.0 cm, 27.0 cm, 53.0 cm, 84.0 cm and 87.0 cm from the proximal end.The embolization coil was stuck within the px slim.Conclusions: evaluation of the returned pc400 and the px slim revealed that the pc400 was stuck inside the px slim due to coagulated blood inside the catheter.During the functional test, the pc400 was unable to be removed from the px slim, and therefore, the functional test could not be performed.While attempting to remove the pc400 from the px slim, the pc400 unintentionally detach inside the catheter.The px slim was visually inspected and no damage was observed on the catheter.Based on the returned condition, the reported complaint could not be determined.Further evaluation of the pc400 revealed kinks on the pusher assembly.This damage was likely incidental to the complaint and could have occurred during packaging for return to penumbra.Penumbra coils and catheters 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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of resistance and inability to advance pc400 within the px slim.This report is associated with mfr report number: 1.3005168196-2020-00998.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10317799
• Report Number: 3005168196-2020-00997
• Device Sequence Number: 3178247
• Product Code: HCG
• UDI-Device Identifier: 00814548010724
• UDI-Public: 00814548010724
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2020
• 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 Expiration Date: 12/01/2020
• Device Model Number: 4002C1660
• Device Catalogue Number: 4002C1660
• Device Lot Number: C04283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Date Report Sent to FDA: 01/01/2005