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

Model Number	400SMTXSFT2H04
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2020
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 bifurcation of the internal carotid artery (ica) using penumbra smart coils (smart coils), non-penumbra coils, non-penumbra microcatheters, a non-penumbra parent catheter, non-penumbra guiding catheter, and stent.During the procedure, the physician implanted a stent in the target vessel with the non-penumbra microcatheter, followed by seven coils and four smart coils with another non-penumbra microcatheter using a transcell technique.Subsequently, after advancing the next smart coil from the distal tip of the second microcatheter and approximately 3cm into the vessel, the smart coil was stuck.Therefore, the smart coil and microcatheter were removed together, and the smart coil was removed from the microcatheter on the back table.The procedure was completed using six non-penumbra coils and a different non-penumbra microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed offset coil winds on its embolization coil.If the smart coil is forcefully manipulated against resistance, damage such as this may occur.Evaluation of the returned non-penumbra microcatheter revealed an undamaged device.During functional testing, the smart coil was advanced through the non-penumbra microcatheter without issue.The root cause of the resistance could not be determined.Penumbra coils are visually 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.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: 11178585
• Report Number: 3005168196-2021-00097
• Device Sequence Number: 2270672
• Product Code: HCG
• UDI-Device Identifier: 00814548015323
• UDI-Public: 00814548015323
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2020
• 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: 12/07/2021
• Device Model Number: 400SMTXSFT2H04
• Device Catalogue Number: 400SMTXSFT2H04
• Device Lot Number: F73063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 02/17/2021
• 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