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

Model Number	400SMTSFT0308
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-01402.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the superior cerebellar artery (sca) using penumbra smart coils (smart coils), a smart coil detachment handle (handle) and a non-penumbra microcatheter.It was noted that the patent's anatomy was tortuous, calcified, and narrowed.During the procedure, the physician placed two smart coils into the target vessel using the microcatheter.Afterwards, the physician advanced the next smart coil into the target vessel using the microcatheter and attempted to detach it using the handle; however, the smart coil failed to detach.The physician then made several additional attempts but the smart coil would not detach.Therefore, the smart coil and handle were removed.The procedure was completed using two other coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil pusher assembly revealed a functional device.The pet lock was broken on the proximal end of the pusher assembly, the pull wire was retracted out of the ddt, and the embolization coil was detached from the pusher assembly.This type of damage typically occurs during a successful detachment.Therefore, the root cause of the reported complaint could not be determined.The detached embolization coil was not returned for evaluation.Further evaluation revealed kinks in the pusher assembly.This damage was incidental to the reported complaint and the root cause could not be determined.Penumbra devices 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: 3005168196-2021-01402 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: 12054785
• Report Number: 3005168196-2021-01401
• Device Sequence Number: 4304424
• Product Code: HCG
• UDI-Device Identifier: 00814548015057
• UDI-Public: 00814548015057
• 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): 06/23/2021
• 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: 03/17/2024
• Device Model Number: 400SMTSFT0308
• Device Catalogue Number: 400SMTSFT0308
• Device Lot Number: F89136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 07/17/2021
• 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