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

Model Number	400SMTSTD0515
Medical Device Problem Codes	Break (1069); 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	12/24/2020
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 anterior communicating artery (acom) using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, the physician attempted to advance a smart coil in the aneurysm; however, the physician was unable to place the smart coil completely in the aneurysm and decided to remove the smart coil.Upon retraction, only part of the smart coil was removed, and the other part of the smart coil got caught in the stent and broke off.It was reported that the part of the smart coil that broke off remains securely in place in the patient¿s vessel.It was also reported that the physician did not experience any significant resistance during the procedure.The procedure was completed using other coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil confirmed that the embolization coil was fractured.Based on the reported event, this damage likely resulted from the embolization coil getting stuck on the stent during removal from the patient.If the embolization coil is forcefully retracted against resistance while stuck in a stent, the coil may fracture.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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 # 02 mfr report: 3005168196-2021-00208.1.Section d.Box 6.If implanted, give date h3 other text : placeholder.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11267920
• Report Number: 3005168196-2021-00208
• Device Sequence Number: 11067452
• Product Code: HCG
• UDI-Device Identifier: 00814548014647
• UDI-Public: 00814548014647
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2021
• 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: 01/27/2024
• Device Model Number: 400SMTSTD0515
• Device Catalogue Number: 400SMTSTD0515
• Device Lot Number: F88180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 03/22/2021; 01/14/2005
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 03/27/2021; 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Date Report Sent to FDA: 01/01/2005