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

Model Number	400SMTXSFT0304
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2020
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 numbers: 3005168196-2020-01451, 3005168196-2020-01452, 3005168196-2020-01453, 3005168196-2020-01454, 3005168196-2020-01455, 3005168196-2020-01456.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar artery using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, a smart coil would not advance in the introducer sheath and was stuck at the initial position.The smart coil was removed.The physician continued with the procedure using another smart coil.However, the same issue occurred, and the second smart coil was removed.Subsequently, the physician advanced four smart coils individually to the target vessel.The handle took two to three attempts to detach the first, second, and third smart coils, and the handle was unable to detach the fourth smart coil.Therefore, the physician used a hemostat to manually detach the fourth smart coil.The procedure was completed using additional smart coils and another handle.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: 10523294
• Report Number: 3005168196-2020-01457
• Device Sequence Number: 19739010
• Product Code: HCG
• UDI-Device Identifier: 00814548015347
• UDI-Public: 00814548015347
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2020
• 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: 06/21/2023
• Device Model Number: 400SMTXSFT0304
• Device Catalogue Number: 400SMTXSFT0304
• Device Lot Number: F84241
• 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: 08/17/2020
• Initial Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005