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

Model Number	400SMTXSFT2H06
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The smart coil was implanted in the patient; however, the pusher assembly 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 numbers: 1.3005168196-2021-02808.2.3005168196-2021-02810.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the posterior communicating artery (pcomm) using a penumbra smart coils (smart coils), penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician advanced a smart coil (lot#f106024) to the target vessel and attempted to detach it using the handle; however, the smart coil failed to detach.Therefore, the physician manually detached the smart coil.The same issue occurred with the second smart coil (lot#f105543); however, the physician was able to detach the smart coil manually.Next, the physician opened a second handle and attempted to detach the third smart coil (lot#f106201); however, the smart coil failed to detach after multiple attempts using the handle as well as manually.Therefore, the physician decided to remove the smart coil.While retracting, the smart coil unintentionally detached inside the microcatheter.The physician then used the pusher assembly to push the detached smart coil into the aneurysm.The physician again experienced difficulty detaching the fourth smart coil (lot#f83607) using the handle; however, the smart coil was able to be detached after multiple clicks.While attempting to detach the fifth smart coil (lot#f107987) using the second handle, the smart coil failed to detach after multiple attempts using the handle as well as manually.Therefore, the physician decided to remove the smart coil.While retracting, the smart coil unintentionally detached inside the microcatheter.The physician then used the pusher assembly to push the detached smart coil into the aneurysm.At this point, the physician decided to change the handle again and attempted to detach the sixth smart coil (lot#f106604); however, the smart coil failed to detach with the third handle as well as manually.Therefore, the smart coil was removed.The same issue occurred with the seventh smart coil (lot#f105953).However, upon retracting, this smart coil unintentionally detached at the hub of the microcatheter.Therefore, the microcatheter containing the detached smart coil was removed.The procedure was completed using non-penumbra coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed that the pet lock was separated, the pull wire was not present, and the pusher assembly was fractured on the proximal end of the pusher assembly.Evaluation also revealed that the pull wire was retracted out of the pusher assembly ddt.This damage was likely due to the detachment attempts made during the procedure and contributed to the successful detachment of the embolization coil.The root cause of the embolization coil not detaching initially could not be determined.Penumbra products 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 numbers: 1.3005168196-2021-02808.2.3005168196-2021-02810 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: 13155346
• Report Number: 3005168196-2021-02809
• Device Sequence Number: 14489972
• Product Code: HCG
• UDI-Device Identifier: 00814548015330
• UDI-Public: 00814548015330
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2022
• 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: 07/26/2026
• Device Model Number: 400SMTXSFT2H06
• Device Catalogue Number: 400SMTXSFT2H06
• Device Lot Number: F107987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2021
• 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: 12/06/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2021
• 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 Age: 69 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Date Report Sent to FDA: 01/01/2005