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

Model Number	400SMTHXSFT0102
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2021-01982, 3005168196-2021-01983.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right middle cerebral artery (mca) bifurcation using penumbra smart coils (smart coil), a penumbra smart coil detachment handle (handle), a non-penumbra microcatheter, and a guidewire.It was noted that the aneurysm was bi-lobed.During the procedure, the physician successfully implanted two smart coils in the larger lobe of the aneurysm using the handle.The physician then advanced another smart coil into the target location and, while positioning the smart coil in the target location, the physician experienced resistance and kinked the pusher assembly of the smart coil.Therefore, the smart coil was retracted and removed.Subsequently, the physician decided to stop coiling the larger lobe of the aneurysm.Next, the physician successfully implanted a smart coil in the smaller lobe of the aneurysm using the handle.While attempting to detach another smart coil in the target location using the handle, the smart coil failed to detach.Subsequently, the physician attempted to reposition the smart coil.However, while repositioning, the physician lost access with the microcatheter.Therefore, the smart coil was also retracted and removed.The physician was satisfied with the results, and the procedure was completed at this point.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12443634
• Report Number: 3005168196-2021-01981
• Device Sequence Number: 17366449
• Product Code: HCG
• UDI-Device Identifier: 00814548015613
• UDI-Public: 00814548015613
• 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
• 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: Health Professional
• Device Expiration Date: 07/24/2023
• Device Model Number: 400SMTHXSFT0102
• Device Catalogue Number: 400SMTHXSFT0102
• Device Lot Number: F84856
• Was Device Available for Evaluation?: No
• 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: 08/20/2021
• Initial 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: 63 YR
• Date Report Sent to FDA: 01/01/2005