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

Model Number	4004C0306
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
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 anterior communicating artery (acom) using a penumbra coil 400 (pc400), a non-penumbra microcatheter, a non-penumbra catheter and a neuron max 6f 088 long sheath (neuron max).During the procedure, a pc400 would not advance into the microcatheter; therefore, the pc400 was removed.The procedure was completed using non-penumbra coils, the same microcatheter, the same catheter and the same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pc400 revealed offset coil winds on the embolization coil.If the pc400 is forcefully manipulated against resistance during use, damage such as offset coil winds may occur.During the functional test, while advancing the pusher assembly through its introducer sheath without an issue, as the embolization coil exited the introducer sheath, it was found to be detached due to a fractured sr wire.This damage was incidental to the reported complaint and likely occurred due to forceful retraction against resistance.Due to the returned condition, the root cause of the reported complaint could not be determined.H6 (4316): the investigation findings do not lead to a clear conclusion about the root cause of the reported complaint due to the return condition.Penumbra coils are visually 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: 11837527
• Report Number: 3005168196-2021-01062
• Device Sequence Number: 2989988
• Product Code: HCG
• UDI-Device Identifier: 00814548010816
• UDI-Public: 00814548010816
• 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): 04/21/2021
• 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: 4004C0306
• Device Catalogue Number: 4004C0306
• Device Lot Number: F89975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Date Report Sent to FDA: 01/01/2005