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

Model Number	400SMTXSFT0206
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
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.This report is associated with mfr report number: 3005168196-2021-01775.
Event or Problem Description
On (b)(6) 2021, the patient underwent a coil embolization procedure to treat a ruptured aneurysm in the left internal carotid artery (ica) and posterior communicating (pcom) artery using penumbra smart coils (smart coil), a non-penumbra microcatheter and a guidewire.During the procedure, the physician implanted eight smart coils in the target location using the microcatheter.While attempting to advance the next smart coil, the physician was unable to advance the smart coil at all past its initial position within its introducer sheath.It was reported that multiple attempts were made to advance the smart coil; however, they were unsuccessful.Therefore, the smart coil was removed.Next, the physician implanted five smart coils in the target location using the microcatheter.After advancing the next smart coil into the target location, the physician attempted to reposition the microcatheter to find a good position for the smart coil.While repositioning the microcatheter, the smart coil and microcatheter extended beyond the aneurysm wall which caused a perforation.The physician then repositioned the microcatheter and smart coil and detached the smart coil in the target location.Additional smart coils were then implanted in the target location to bridge the point of perforation and close the portion of the aneurysm dome.Subsequently, it was noticed that there was a brief and small amount of contrast extravasation which quickly sealed.It was reported there was no change in the patient¿s vitals.The event was considered resolved the same day (b)(6) 2021.The aneurysm perforation was reported to be a serious adverse event with a definite relationship to the smart coil and index procedure.
Additional Manufacturer Narrative
Evaluation of the returned smart coil was unable to confirm the reported complaint.Evaluation revealed that the pusher assembly mid-joint was retracted past the introducer sheath friction lock.If this occurs, resistance will likely be experienced when attempting to advance back through the friction lock.During functional testing, the pusher assembly mid-joint was able to be advanced through the friction lock with resistance.After the pusher assembly was advanced through the friction lock, the smart coil was advanced through its introducer sheath without an issue.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.This report is associated with mfr report number: 1.3005168196-2021-01775.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12297627
• Report Number: 3005168196-2021-01774
• Device Sequence Number: 3180946
• Product Code: HCG
• UDI-Device Identifier: 00814548016030
• UDI-Public: 00814548016030
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 09/08/2021
• 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: No Information
• Device Expiration Date: 03/18/2026
• Device Model Number: 400SMTXSFT0206
• Device Catalogue Number: 400SMTXSFT0206
• Device Lot Number: F104708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Date Report Sent to FDA: 01/01/2005