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

Model Number	400SMTXSFT0102
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Separation Problem (4043)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2020
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 number: 3005168196-2020-02264.
Event or Problem Description
The patient was undergoing coil embolization procedure using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, the physician advanced a smart coil into the target location, however, decided to reposition the smart coil.While retracting the smart coil, the physician experienced resistance and subsequently, the smart coil unintentionally detached.The physician then used the pusher assembly of the smart coil to successfully push the smart coil back into the aneurysm.Afterwards, the physician advanced another smart coil into the microcatheter.Then, to test the smart coil the physician advanced and retracted the smart coil several times in the proximal end of the microcatheter and the physician experienced resistance while retracting the smart coil.Subsequently, the smart coil unintentionally detached.The physician then used the pusher assembly of the smart coil to successfully push the smart coil back into the aneurysm.The procedure ended at this point.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: 10999075
• Report Number: 3005168196-2020-02263
• Device Sequence Number: 3562330
• Product Code: HCG
• UDI-Device Identifier: 00814548015187
• UDI-Public: 00814548015187
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/16/2020
• 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: 11/05/2024
• Device Model Number: 400SMTXSFT0102
• Device Catalogue Number: 400SMTXSFT0102
• Device Lot Number: F94118
• 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: 11/16/2020
• Initial Report FDA Received Date: 12/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Date Report Sent to FDA: 01/01/2005