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

Model Number	4006U0304-A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 basilar artery using penumbra coils 400 (pc400s) and a px slim delivery microcatheter (px slim.During the procedure, a pc400 would not detach.The physician attempted to manually detach the pc400 with the hemostats but was unsuccessful.The physician removed both the px slim and pc400, and the pc400 came out of the px slim detached.The procedure was completed using non-penumbra coils and a non-penumbra microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pc400 embolization coil revealed that the proximal constraint sphere was intact at the proximal end of the embolization coil.This indicates that the embolization coil was detached as indented.The pc400 pusher assembly was not returned for evaluation; therefore, the root cause of the reported complaint could not be determined.Further evaluation of the returned embolization coil revealed offset coil winds.This damage was likely incidental to the complaint.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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported complaint due to the missing pusher assembly.H3 other text : placeholder.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11692981
• Report Number: 3005168196-2021-00783
• Device Sequence Number: 3437350
• Product Code: HCG
• UDI-Device Identifier: 00814548019505
• UDI-Public: 00814548019505
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 03/22/2021
• 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: 4006U0304-A
• Device Catalogue Number: 4006U0304
• Device Lot Number: C23533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement 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
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005