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

Model Number	400SMTHXSFT0206
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left middle cerebral artery (mca) using penumbra smart coils (smart coils), a benchmark 6f 071 delivery catheter (benchmark), a neuron select catheter 5f (5f select), and a non-penumbra microcatheter.During the procedure, the physician implanted four smart coils into the target vessel.While advancing the next smart coil, it was unable to advance past its initial position within its introducer sheath.Therefore, the smart coil was removed.No additional coils were needed and therefore, the procedure was ended.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information provided by the sales representative on (b)(6) 2020: the product was disposed of by the hospital and is no longer available for return.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.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right middle cerebral artery (mca) using penumbra smart coils (smart coils), a benchmark 6f 071 delivery catheter (benchmark), a neuron select catheter 5f (5f select), and a non-penumbra microcatheter.During the procedure, the physician implanted four smart coils into the target vessel.While advancing the next smart coil, it was unable to advance into the hub of microcatheter.Therefore, the smart coil was removed.No additional coils were needed and therefore, the procedure was ended.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: 10587836
• Report Number: 3005168196-2020-01576
• Device Sequence Number: 11074128
• Product Code: HCG
• UDI-Device Identifier: 00814548015972
• UDI-Public: 00814548015972
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 08/26/2020
• 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: 06/01/2025
• Device Model Number: 400SMTHXSFT0206
• Device Catalogue Number: 400SMTHXSFT0206
• Device Lot Number: F98175
• 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: 08/26/2020
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Date Report Sent to FDA: 01/01/2005