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

Catalog Number	4002C0720
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Neurological Deficit/Dysfunction (1982)
Date of Event	08/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Potential adverse events with the penumbra coil 400 (pc400) system include neurological deficits and are included in the labeling.Therefore, it was determined that the reported focal neurological deficit was a potential complication related to the use of the pc400 system.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 1.3005168196-2017-01983.2.3005168196-2017-01984.3.3005168196-2017-01985.4.3005168196-2017-01986.Please note that this patient experienced another event reported under the following mfr report numbers: 1.3005168196-2017-01408.2.3005168196-2017-01409.The device was implanted into the patient.
Event or Problem Description
On (b)(6) 2017, the patient underwent a coil embolization procedure using penumbra coil 400''s (pc400''s) with no report of an adverse effect to the patient.On (b)(6) 2017, the patient presented at the hospital with a right arm and leg sensation change.The right arm sensation resolved spontaneously; however, the patient had decreased sensation below the knee and a cold feeling was present.The patient''s national institutes of health stroke scale (nihss) score at baseline was a 3.The results of the computerized tomography (ct) head and computerized tomography angiography (cta) were negative at baseline.The patient was given intravenous tissue plasminogen activator (iv-tpa) and the symptoms resolved on (b)(6) 2017.The reported focal neurological deficit was adjudicated to be an adverse event that was possibly related to the pc400 but unrelated to the procedure.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7033340
• Report Number: 3005168196-2017-01982
• Device Sequence Number: 16476801
• Product Code: HCG
• UDI-Device Identifier: 00814548010540
• UDI-Public: 00814548010540
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Catalogue Number: 4002C0720
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2017
• Initial Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 66 YR