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

Model Number	400SMTXSFT0304
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2021-00837, 3005168196-2021-00838, 3005168196-2021-00840, 3005168196-2021-00841, 3005168196-2021-00842.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra smart coils (smart coils), penumbra smart coil detachment handles (handles), and two non-penumbra microcatheters.During the procedure, the first smart coil would not detach after multiple attempts were made with three handles.While retracting the smart coil, the physician experienced resistance, and the smart coil was stuck in the first microcatheter.The smart coil was then removed.Subsequently, the physician used a second smart coil, the third handle, and the same microcatheter.However, the physician was also unable to detach the smart coil with the handle after multiple attempts were made.While retracting the smart coil, the physician experienced resistance, and the smart coil was stuck in the microcatheter.The smart coil and microcatheter were then removed.The physician resumed the procedure and successfully placed the third smart coil with the handle and second microcatheter.Next, the physician used a fourth smart coil, the same handle, and the same second microcatheter.However, the physician was also unable to detach the smart coil with the handle after multiple attempts were made and removed the smart coil.It was reported that this was the last attempted embolization.Therefore, the procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil pusher assembly revealed that the pet lock was separated, the pull wire was retracted on the proximal end of the pusher assembly, the pusher assembly had bends and kinks throughout its length, the braided shaft was damaged, the pull wire was retracted out of the pusher assembly ddt and the embolization coil was detached from the pusher assembly and not returned for evaluation.Due to the return damage, the root cause of the reported complaint could not be determined.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of detachment failure 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: 1.3005168196-2021-00837, 2.3005168196-2021-00838, 3.3005168196-2021-00840, 4.3005168196-2021-00841, 5.3005168196-2021-00842.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11716633
• Report Number: 3005168196-2021-00839
• Device Sequence Number: 19840218
• Product Code: HCG
• UDI-Device Identifier: 00814548015347
• UDI-Public: 00814548015347
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021
• 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: 06/21/2023
• Device Model Number: 400SMTXSFT0304
• Device Catalogue Number: 400SMTXSFT0304
• Device Lot Number: F84241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 06/02/2021
• 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