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

Catalog Number	4004C0820
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2017
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 numbers: 3005168196-2017-00976, 3005168196-2017-00977, the hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the thoracic artery using penumbra coil 400''s (pc400's) and two penumbra coil detachment handles (dh1''s).During the procedure, the physician advanced a px slim delivery microcatheter (px slim) towards the target vessel, then deployed and detached three pc400''s using the first dh1.Next, the physician deployed a new pc400 into the target vessel and then attempted to detach it using the same dh1.However, after several attempts, the physician was unable to detach the coil using the dh1 and decided to open a new dh1; however, the physician was still unable to detach the pc400 with this second dh1.Therefore, the pc400 was retracted and the procedure was completed using a new pc400, the same px slim and the second dh1.There was no report of an adverse effect to the patient.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: 6659331
• Report Number: 3005168196-2017-00975
• Device Sequence Number: 19265846
• Product Code: HCG
• UDI-Device Identifier: 00814548010922
• UDI-Public: 00814548010922
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2017

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: 04/24/2024
• Device Catalogue Number: 4004C0820
• Device Lot Number: F69106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2017
• Initial Report FDA Received Date: 06/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1