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

Catalog Number	400SMTXSFT0101
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2018
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: 3005168196-2018-01455.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, the physician placed four smart coils in the target vessel using a non-penumbra microcatheter and a handle.The physician then advanced a new smart coil in the target vessel and used the handle to detach it; however, the smart coil failed to detach.Therefore, the physician decided to withdraw it; however, as the physician was pulling the smart coil back, it unintentionally detached inside the microcatheter.The physician then used a wire to successfully push the detached coil into the aneurysm.The procedure was completed using the same microcatheter, the same handle and another smart coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This report is associated with mfr report number: 3005168196-2018-01455.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7716133
• Report Number: 3005168196-2018-01454
• Device Sequence Number: 903827
• Product Code: HCG
• UDI-Device Identifier: 00814548015163
• UDI-Public: 00814548015163
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 06/25/2018
• 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: 08/22/2022
• Device Catalogue Number: 400SMTXSFT0101
• Device Lot Number: F78795
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005