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

Catalog Number	4004C1030
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was disposed of by the hospital and is no longer available for return.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2018-00199, 3005168196-2018-00200.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal iliac artery (iia) using penumbra coil 400''s (pc400s) and a penumbra coil detachment handle (handle).It was noted that the patient's anatomy was slightly curved.During the procedure, the physician deployed and detached three pc400''s into the target vessel using a px slim delivery microcatheter (px slim) and the handle.The physician then advanced a new pc400 (lot #f72631) into the target vessel and attempted to detach it using the same handle; however, the pc400 failed to detach.After four to five failed attempts, the pc400 was removed.The physician continued the procedure by deploying and detaching ten additional pc400''s using the same px slim and handle.While attempting to advance a new pc400 (lot #f68287) through the px slim, the physician experienced resistance about half way through the px slim and decided to forcefully remove the pc400.The procedure was then completed using fourteen additional pc400s, two smart coils, the same px slim and the same handle.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: 7208716
• Report Number: 3005168196-2018-00201
• Device Sequence Number: 10962906
• Product Code: HCG
• UDI-Device Identifier: 00814548010977
• UDI-Public: 00814548010977
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2017

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: Physician
• Device Expiration Date: 10/31/2024
• Device Catalogue Number: 4004C1030
• Device Lot Number: F72631
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 01/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR