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

Model Number	400SMTXSFT0206
Medical Device Problem Codes	Separation Failure (2547); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
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 number: 3005168196-2020-02187.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the posterior cerebral artery (pca) using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), non-penumbra stent, non-penumbra microcatheter, non-penumbra access catheter, and non-penumbra sheath.During the procedure, the physician implanted a stent and two smart coils in the target location.While detaching the final smart coil with the handle, the black alignment zone separated, but the physician was unable to confirm if the smart coil had detached.Subsequently, the pusher assembly of the smart coil became stuck in the microcatheter.The physician then made multiple attempts to remove the smart coil and microcatheter.Each time the physician attempted to remove the smart coil and microcatheter, the smart coil would pull on the stent and coil mass, as well as the microcatheter becoming stuck on one of the stent tines at a certain point.Therefore, the physician decided to cut the proximal end of the microcatheter and pusher assembly at the groin region.The remaining part of the pusher assembly and microcatheter were left in the patient.The procedure ended 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: 10954068
• Report Number: 3005168196-2020-02186
• Device Sequence Number: 2420232
• Product Code: HCG
• UDI-Device Identifier: 00814548016030
• UDI-Public: 00814548016030
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/15/2025
• Device Model Number: 400SMTXSFT0206
• Device Catalogue Number: 400SMTXSFT0206
• Device Lot Number: F95641
• 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: 11/09/2020
• Initial Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Date Report Sent to FDA: 01/01/2005