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

Catalog Number	4006U0308
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2016
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 hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400's (pc400).During the procedure, the physician successfully placed a pc400 in the target vessel using a px slim delivery microcatheter (px slim).While advancing a new pc400 through the px slim, the pc400 unintentionally detached at the tip of the px slim and was pushed into the aneurysm.The physician then removed the px slim and the procedure was completed using another manufacturer's coil and microcatheter.It should be noted the physician used a rotating hemostasis valve (rhv) and maintained continuous flush during the procedure.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: 6071428
• Report Number: 3005168196-2016-01548
• Device Sequence Number: 339372
• Product Code: HCG
• UDI-Device Identifier: 00814548011448
• UDI-Public: 00814548011448
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 10/04/2016

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: Pharmacist
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 4006U0308
• Device Lot Number: F34835
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2016
• Initial Report FDA Received Date: 11/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1