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

Catalog Number	4006C0303
Medical Device Problem Codes	Detachment Of Device Component (1104); Inadequacy of Device Shape and/or Size (1583); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2016
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.This report is associated with mfr report number: 3005168196-2016-01785.The hospital disposed of the device because the patient has an infection.
Event or Problem Description
The patient was undergoing a coil embolization in the inferior mesenteric artery (ima) using penumbra coil 400¿s (pc400).It was noted that the patient's anatomy was tortuous.During the procedure, the physician advanced a px slim delivery microcatheter (px slim) and a micro guidewire in the patient¿s body.Although the micro guidewire advanced toward the target portion of the ima, the px slim would not advance smoothly.Therefore, the micro guidewire was removed and replaced with another guidewire and the physician advanced a 3 millimeters pc400 into the aneurysm.However, due to the large size of the aneurysm, the pc400 did not properly fill the aneurysm; therefore, the physician decided to re-sheath it.While retracting the pc400 coil through the px slim in order to resheath it, the physician first experienced resistance and then no resistance was experienced afterward.Suspecting the possibility of an unintentional detachment of the pc400 in the px slim, the physician performed an angiography which confirmed that the pc400 had unintentionally detached near the hub of the px slim.After an unsuccessfully attempted to push the detached pc400 out of the px slim and into the aneurysm, the physician cut off the proximal portion of the px slim containing the detached pc400 with a pair of scissors, and removed the detached pc400.The procedure was then completed using the same guide wire, a new px slim and two new pc400.It should be noted that the physician used a rotating hemostasis valve (rhv) but did not use continuous flush; however, manual flush was performed before each 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: 6149813
• Report Number: 3005168196-2016-01784
• Device Sequence Number: 10982010
• Product Code: HCG
• UDI-Device Identifier: 00814548011806
• UDI-Public: 00814548011806
• 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): 11/09/2016

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: 06/30/2021
• Device Catalogue Number: 4006C0303
• Device Lot Number: F36090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2016
• Initial Report FDA Received Date: 12/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1