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

Catalog Number	400SMTXSFT3H08
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2018
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 device was implanted in the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left carotid cave using penumbra smart coils (smart coils).During the procedure, approximately one centimeter of the third smart coil prolapsed into the parent artery lumen.It is unclear if there was a detachment issue or if the coil prolapse was due to tension within the system itself.The procedure was completed using an additional smart coil.The patient was discharged the next day, (b)(6) 2018 and there was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7464678
• Report Number: 3005168196-2018-00865
• Device Sequence Number: 1544341
• Product Code: HCG
• UDI-Device Identifier: 00814548017129
• UDI-Public: 00814548017129
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2018

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: 05/08/2022
• Device Catalogue Number: 400SMTXSFT3H08
• Device Lot Number: F76997
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR