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

Catalog Number	400SMTSTD0830
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2018
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.This report is associated with mfr report numbers: 3005168196-2018-01925; 3005168196-2018-01926; 3005168196-2018-01928.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils) and a smart coil detachment handle (handle).During the procedure, the physician inserted a non-penumbra microcatheter into the target location and attempted to place a smart coil, however, the physician repeatedly advanced and retracted the smart coil to reposition it.Consequently, the physician began to experience resistance while advancing near the distal tip of the microcatheter and, therefore, the smart coil was removed.This then occurred with a second smart coil.The physician then successfully placed a smart coil in the target location, however, was unable to detach the coil using the handle.It was reported that there was an abnormal sound when the physician attempted to detach the smart coil with the handle.The physician therefore used a second handle to detach the smart coil.The procedure was then completed using the second handle and additional smart coils.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: 7919197
• Report Number: 3005168196-2018-01927
• Device Sequence Number: 1913802
• Product Code: HCG
• UDI-Device Identifier: 00814548014524
• UDI-Public: 00814548014524
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2018
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 02/06/2023
• Device Catalogue Number: 400SMTSTD0830
• Device Lot Number: F81799
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005