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

Model Number	400SMTHXSFT2H04
Medical Device Problem Codes	Migration (4003); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2021
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 a2 segment of the right internal carotid artery (ica) using penumbra smart coils (smart coil) and a penumbra smart coil detachment handle (handle).It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician implanted a smart coil in the target vessel.The physician then advanced another smart coil into the target location and attempted to detach it using a handle; however, the smart coil did not fully detach with the alignment zone not completely separated.Subsequently, the physician retracted the pusher assembly and noticed the smart coil was still attached under angiography from the origin of the inner carotid artery.The physician continued retracting the pusher assembly under angiography and noticed that the smart coil had unintentionally detached, and the smart coil was at the distal end of the microcatheter.The physician was unable to push the detached smart coil into the aneurysm using the pusher assembly and the smart coil moved into the parent vessel.Therefore, the physician used a stent to press the smart coil against the vessel wall.It was also reported that the parent vessel was able to keep its patency.The procedure ended the procedure at this point.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 detached from the pusher assembly.Further evaluation revealed that the pet lock was broken and separated on the proximal end of the pusher assembly, the pull wire was retracted out of the ddt, which resulted in the embolization coil detaching from the pusher assembly.This damage typically occurs due to successful detachment.The detached embolization coil was not returned for evaluation.Therefore, the root cause of the reported complaint could not be determined.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported initial detachment issue on the smart coil 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.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: 12097186
• Report Number: 3005168196-2021-01444
• Device Sequence Number: 17125067
• Product Code: HCG
• UDI-Device Identifier: 00814548015750
• UDI-Public: 00814548015750
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021
• 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: 10/19/2025
• Device Model Number: 400SMTHXSFT2H04
• Device Catalogue Number: 400SMTHXSFT2H04
• Device Lot Number: F101264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Date Report Sent to FDA: 01/01/2005