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

Catalog Number	400SMTXSFT2H03
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2019
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 number: 3005168196-2019-02202.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle cerebral artery (mca) using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, a smart coil was advanced to the target location.The physician then retracted and advanced the smart coil approximately 2-3 times until the coil took its intended shape.Next, the physician detached the smart coil using the handle.However, when the pusher assembly of the smart coil was pulled, the physician noticed the smart coil was retracted a few centimeters with the pusher assembly and did not detach.The smart coil was then re-advanced into the target vessel and the physician made another attempt to detach it using the handle.However, the smart coil still did not detach; therefore, the physician decided to break the proximal end of the pusher assembly to manually detach the smart coil.After a few attempts, the smart coil detached and was implanted into the target location.The procedure was completed using another coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
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: 3005168196-2019-02202.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9372518
• Report Number: 3005168196-2019-02201
• Device Sequence Number: 19389338
• Product Code: HCG
• UDI-Device Identifier: 00814548015316
• UDI-Public: 00814548015316
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019
• 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: 08/08/2023
• Device Catalogue Number: 400SMTXSFT2H03
• Device Lot Number: F85170
• 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: 10/30/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005