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

Catalog Number	4006C0408
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage, Subarachnoid (1893)
Date of Event	10/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is associated with mfr report numbers: 1.3005168196-2016-01631, 2.3005168196-2016-01700, 3.3005168196-2016-01701, 4.3005168196-2016-01702, 5.3005168196-2016-01703, 6.3005168196-2016-01704, 7.3005168196-2016-01705, 8.3005168196-2016-01706, 9.3005168196-2016-01707, 10.3005168196-2016-01708, 11.3005168196-2016-01709, 12.3005168196-2016-01710, 13.3005168196-2016-01711, 14.3005168196-2016-01712, 15.3005168196-2016-01713, 16.3005168196-2016-01714, 17.3005168196-2016-01715, 18.3005168196-2016-01716, 19.3005168196-2016-01717, 20.3005168196-2016-01718, 21.3005168196-2016-01719, 22.3005168196-2016-01720, 23.3005168196-2016-01721, 24.3005168196-2016-01722, 25.3005168196-2016-01723, 26.3005168196-2016-01724, 27.3005168196-2016-01725, 28.3005168196-2016-01726.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 remains implanted in the patient.
Event or Problem Description
The patient was undergoing a coil embolization in the left internal carotid artery (ica) procedure using penumbra coil 400s (pc400).During the procedure, while advancing the 28th pc400 through the px slim delivery catheter (px slim) the physician experienced resistance and the pc400 unintentionally detached within the px slim.The physician then removed the px slim in order to remove the detached pc400.The procedure was completed using the same px slim and a new pc400.After the procedure, the patient¿s condition worsened and a computerized tomography (ct) confirmed that the patient suffered a subarachnoid hemorrhage (sah) which was believed to be from the aneurysm.It is unknown what caused this sah.The patient underwent an additional procedure to embolize the parent vessel using non-penumbra coils in order to treat this sah; the procedure was successful and the patient¿s condition was stabilized.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6131917
• Report Number: 3005168196-2016-01727
• Device Sequence Number: 11051422
• 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
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/30/2016

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 Expiration Date: 05/15/2024
• Device Catalogue Number: 4006C0408
• Device Lot Number: F69348
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2016
• Initial Report FDA Received Date: 11/29/2016
• 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: Required Intervention
• Patient Age: 59 YR