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

Model Number	400SMTSFT0515
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastric artery using penumbra smart coils (smart coil), penumbra smart coil detachment handle (handle), pushable coil, and non-penumbra microcatheter.During the procedure, the physician placed three smart coils and a pushable coil in the target vessel using the microcatheter.The physician then advanced another smart coil into the aneurysm and used the handle to detach it; however, the smart coil failed to detach.It was also reported that the alignment zone of the smart coil was separated only a centimeter.The physician pulled the pusher assembly of the smart coil in an attempt to manually detach it but, the smart coil still failed to detach.Therefore, it was removed.The procedure was completed using a new smart coil and the same handle.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 intact with the pusher assembly.Further evaluation revealed that the pet lock was separated, and the pull wire was not present on the proximal end of the pusher assembly, the pusher assembly had kinks and the pull wire was within the pusher assembly ddt.If the device is manipulated against resistance or is otherwise mishandled at extreme angles during use, damage such as pusher assembly kinks may occur.If the pusher assembly is kinked, the pull wire may become pinned within the pusher assembly and prevent the pull wire from retracting during an attempt to detach the embolization coil.The pull wire was not present on the proximal end; therefore, the device could not be functionally tested.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.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: 12140258
• Report Number: 3005168196-2021-01506
• Device Sequence Number: 4131067
• Product Code: HCG
• UDI-Device Identifier: 00814548014944
• UDI-Public: 00814548014944
• 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): 07/08/2021
• 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: 06/17/2024
• Device Model Number: 400SMTSFT0515
• Device Catalogue Number: 400SMTSFT0515
• Device Lot Number: F91078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 07/30/2021
• 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