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

Model Number	400SMTHXSFT0204
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the paraclinoid internal carotid artery (ica) using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.It should be noted that the patient''s anatomy was tortuous.During the procedure, the physician successfully implanted two non-penumbra coils and one smart coil.After advancing the next smart coil into the target location, the physician attempted to detach it by using the handle and by manual detachment but was unsuccessful.It was reported that the smart coil alignment zone was separated but the coil was not detached.Therefore, the smart coil was removed.The procedure was completed using two smart coils, the same handle, two other coils, and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed that the embolization coil was detached from its pusher assembly, and the complaint could not be confirmed.Further evaluation revealed that the pet lock was separated on the proximal end of the pusher assembly, and the pull wire was retracted from its original position within the ddt.This type of damage typically results from a successful detachment during an attempt to detach the embolization coil.Based on the returned condition of the device, the root cause of the reported complaint 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.

• 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: 12849354
• Report Number: 3005168196-2021-02640
• Device Sequence Number: 4350984
• Product Code: HCG
• UDI-Device Identifier: 00814548015712
• UDI-Public: 00814548015712
• 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: 05/17/2026
• Device Model Number: 400SMTHXSFT0204
• Device Catalogue Number: 400SMTHXSFT0204
• Device Lot Number: F106348
• 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: 10/25/2021
• Initial Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2021
• 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: 72 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005