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	10/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed that the embolization coil was intact with its pusher assembly, and the complaint was confirmed.Evaluation revealed that the pet lock was separated on the proximal end of the pusher assembly, the pusher assembly was kinked, and coagulated blood was present within the ddt.The pet lock separation likely occurred during the attempt to detach the embolization coil during the procedure.The pusher assembly kink and coagulated blood inside the ddt was incidental to the reported complaint.During the functional test, the embolization coil was unable to be detached from its pusher assembly using a demonstration handle, and no further testing could be performed.The root cause of the complaint 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.The investigation findings do not lead to a clear conclusion about the root cause of the smart coil''s inability to detach.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle cerebral artery (mca) using a penumbra smart coil (smart coil), a penumbra smart coil detachment handle (handle), benchmark 6f 071 delivery catheter (benchmark), non-penumbra microcatheters, and a non-penumbra balloon catheter.It was noted that the patient¿s anatomy was moderately tortuous and calcified.During the procedure, the physician placed seven non-penumbra coils in the anterior communicating artery (acom) using the microcatheter.The physician then decided to remove and exchange to another microcatheter.Subsequently, the physician advanced a smart coil through the microcatheter against resistance and placed the coil in the mca aneurysm; however, the physician was unable to detach the smart coil using the handle.Therefore, the smart coil and handle were removed.The procedure was completed using other coils and the same microcatheter.There was no report of an adverse effect to the patient.

• 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: 12848697
• Report Number: 3005168196-2021-02637
• Device Sequence Number: 4672037
• Product Code: HCG
• UDI-Device Identifier: 00814548015057
• UDI-Public: 00814548015057
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2021
• 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: 04/27/2026
• Device Model Number: 400SMTSFT0308
• Device Catalogue Number: 400SMTSFT0308
• Device Lot Number: F105792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• 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: 10/26/2021
• Initial Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005