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

Model Number	400SMTHXSFT0204
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
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.This report is associated with mfr report number: 3005168196-2021-01747.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, the physician implanted coils in the target location.Subsequently, while the hospital tech was attempting to advance a smart coil (f102548), the pusher assembly kinked when the smart coil was at the starting position of the introducer sheath.The smart coil was then removed.Next, while the physician was retracting a smart coil (f81966) to reposition the tip of the microcatheter, the smart coil broke off between the left ica and the stent.The physician decided to have the smart coil remain in the patient as the smart coil was secured between the stent and vessel wall.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report:3005168196-2021-01748 1.Section d.Box 4.Lot#.2.Section d.Box 4.Expiration date.3.Section d.Box 4.Unique identifier.Evaluation of the first returned smart coil confirmed that the embolization coil was detached.Further evaluation revealed that the pusher assembly was kinked in multiple locations throughout its length, the pusher assembly was fractured, and the pull wire was retracted out of the ddt.If the smart coil is forcefully manipulated against resistance during use, damage such as a kink and subsequent fracture may occur.If the pusher assembly becomes fractured and the pull wire is retracted out of the ddt, the embolization coil will detach from the pusher assembly.Evaluation of the second returned smart coil could not confirm the reported pusher assembly being kinked at the starting position.Further evaluation revealed that the pusher assembly was kinked on its proximal end, the introducer sheath was not returned, and the embolization coil had offset coil winds.This damage was incidental to the reported complaint, and the root cause could not be determined.During the functional test, resistance was encountered while attempting to load a demonstration introducer sheath on the pusher assembly due to a kink, and the introducer sheath could not be advanced any further.Therefore, no further functional testing could be performed.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.This report is associated with mfr report number: 1.3005168196-2021-01747.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12278317
• Report Number: 3005168196-2021-01748
• Device Sequence Number: 11787472
• Product Code: HCG
• UDI-Device Identifier: 00814548015712
• UDI-Public: 00814548015712
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2021
• 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: 12/06/2025
• Device Model Number: 400SMTHXSFT0204
• Device Catalogue Number: 400SMTHXSFT0204
• Device Lot Number: F102548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Is the Reporter a Health Professional?: Yes
• 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: 07/15/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 89 KG
• Date Report Sent to FDA: 01/01/2005