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

Model Number	400SMTHXSFT1H02
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
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: 3005168196-2021-00474, 3005168196-2021-00475.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using penumbra smart coils (smart coil) and a non-penumbra microcatheter.During the procedure, the physician placed two smart coils in the target vessel using the microcatheter.While attempting to place two additional smart coils in the target location, the physician experienced resistance and was only able to advance the smart coils partially through the microcatheter.Therefore, both smart coils were removed.Subsequently, the physician experienced the same resistance advancing a new smart coil through the microcatheter; however, the physician was able to advance the smart coil through the resistance and successfully place the smart coil in the target location.The procedure had ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being included on this follow-up #01 mfr report:3005168196-2021-00476.1.Section d.Box 6.If implanted, give date.This report is associated with mfr report numbers: 1.3005168196-2021-00474, 2.3005168196-2021-00475.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 11456923
• Report Number: 3005168196-2021-00476
• Device Sequence Number: 19845875
• Product Code: HCG
• UDI-Device Identifier: 00814548015651
• UDI-Public: 00814548015651
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2022
• 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: 03/15/2022
• Device Model Number: 400SMTHXSFT1H02
• Device Catalogue Number: 400SMTHXSFT1H02
• Device Lot Number: F80411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 02/12/2021
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005