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

Model Number	4006C0202-A
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pc400 confirmed kinks in the introducer sheath.During functional testing, the pc400 was advanced through its introducer sheath with resistance due to the kinks in the introducer sheath.The pc400 was advanced through a demonstration lantern without an issue.The kink in the introducer sheath was likely a result of mishandling during use and likely contributed to resistance during the procedure.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra coils 400 (pc400s) and a px slim delivery microcatheter (px slim).During the procedure, the physician placed seven pc400s into the target vessel using the px slim.While attempting to advance the eighth pc400 out of its introducer sheath and into the px slim, the physician experienced resistance.Subsequently, the physician kinked the introducer sheath of the pc400 and consequently, the pc400 would not advance into the px slim.Therefore, the pc400 was removed.The procedure was completed using additional pc400s and the same px slim.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11769996
• Report Number: 3005168196-2021-00938
• Device Sequence Number: 3777986
• Product Code: HCG
• UDI-Device Identifier: 00814548018126
• UDI-Public: 00814548018126
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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
• Report Date (Section B): 04/06/2021
• 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: 4006C0202-A
• Device Catalogue Number: 4006C0202
• Device Lot Number: F90345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005