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

Catalog Number	4006C0408
Medical Device Problem Codes	Separation Failure (2547); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.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 number: 3005168196-2017-02219.The device was implanted into the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using penumbra coil 400 detachment handles (handles) and penumbra coil 400s (pc400s).It was noted that the patient anatomy was tortuous.During the procedure, the physician deployed and detached two pod coils and pc400s in the target vessel using a px slim delivery microcatheter (px slim).After that, the physician advanced a new pc400 in the target vessel and attempted to detach it using the handle; however, the pc400 failed to detach.It was reported that the pet lock was separated about two millimeters.After several failed attempts, a new handle was opened and the pc400 was successfully detached.The physician continued the procedure by placing additional coils.While attempting to advance a new pc400 as the 27th coil through the px slim, the pc400 would not advance further after reaching almost the distal tip of the px slim.Therefore, it was removed, flushed with saline and re-inserted into the px slim; however, the same issue occurred.Therefore, the pc400 was removed and the procedure was completed using seven additional coils 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: 7129820
• Report Number: 3005168196-2017-02218
• Device Sequence Number: 11076710
• Product Code: HCG
• UDI-Device Identifier: 00814548011905
• UDI-Public: 00814548011905
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2017

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: 03/26/2025
• Device Catalogue Number: 4006C0408
• Device Lot Number: F75236
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2017
• Initial Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1