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

Catalog Number	4006C0306
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Physical Resistance (2578); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2016
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.The device was implanted in the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the proper hepatic artery using penumbra coil 400s (pc400''s).During the procedure, the physician advanced another manufacturers 4-french shepherd hook catheter into the celiac artery and then advanced a px slim delivery microcatheter (px slim) through the catheter toward the target vessel.While advancing a pc400 through the px slim, the physician did not encounter any resistance; however, the px slim came out of the target vessel.Therefore, the physician retracted and re-sheathed the pc400 back into its introducer sheath.The physician then re-advanced the px slim toward the target vessel and re-attempted to advance the previous pc400 through the px slim; however, resistance was encountered and the pc400 would not advance further.Therefore, the pc400 was removed and a new pc400 was opened.The physician deployed and detached the new pc400 into the aneurysm using the px slim.The physician then redeployed and detached the previous pc400 into the aneurysm using the same px slim to complete the procedure.It should be noted that the physician did not use a rotating hemostasis valve (rhv) and did not maintain a continuous flush during the procedure.However, the px slim was flushed before every coil insertion.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: 6105047
• Report Number: 3005168196-2016-01611
• Device Sequence Number: 695057
• Product Code: HCG
• UDI-Device Identifier: 00814548011837
• UDI-Public: 00814548011837
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2016

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: 02/03/2024
• Device Catalogue Number: 4006C0306
• Device Lot Number: F67756
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2016
• Initial Report FDA Received Date: 11/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR