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

Model Number	400SMTHXSFT0306
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2020
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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 3005168196-2020-01554, 3005168196-2020-01555, 3005168196-2020-01556.
Event or Problem Description
The patient was undergoing coil embolization procedure in the anterior communicating artery (acom) using penumbra smart coils, a penumbra smart coil detachment handle (handle) and a non-penumbra microcatheter.During the procedure, the physician advanced a smart coil into the target vessel using the microcatheter and attempted to detach it using the handle; however, the smart coil failed to detach.The physician then attempted to manually detach the smart coil by pulling the proximal portion of the delivery system and after two attempts the smart coil detached.Next, while advancing the second smart coil through the microcatheter, the smart coil became stuck inside the microcatheter.Therefore, the smart coil was removed.Then, while advancing the third smart coil through the microcatheter, the same issue occurred.Therefore, the smart coil and the microcatheter were removed.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: 10584068
• Report Number: 3005168196-2020-01553
• Device Sequence Number: 2627899
• Product Code: HCG
• UDI-Device Identifier: 00814548015781
• UDI-Public: 00814548015781
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2020
• 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 Model Number: 400SMTHXSFT0306
• Device Catalogue Number: 400SMTHXSFT0306
• 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: 08/31/2020
• Initial Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Date Report Sent to FDA: 01/01/2005