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

Model Number	400SMTXSFT0101
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
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 number: 3005168196-2021-00906.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the superior cerebellum vessel using penumbra smart coils (smart coil), penumbra non-penumbra sheath, non-penumbra catheter, and non-penumbra microcatheter.During the procedure, one smart coil was successfully implanted in the target location using the microcatheter.While attempting to place a second smart coil into the target vessel, the penumbra smart coil detachment handle (handle) was unable to detach it.The physician then decided to remove smart coil.However, while retracting, the smart coil had unintentionally detached inside the microcatheter.The physician then injected saline through the microcatheter to push the detached smart coil back into the aneurysm.While attempting to place a third smart coil in the target location, the physician noticed that the smart coil would not advance from the starting position within the introducer sheath.Therefore, it was removed.The procedure was completed.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: 11749768
• Report Number: 3005168196-2021-00907
• Device Sequence Number: 4319007
• Product Code: HCG
• UDI-Device Identifier: 00814548015163
• UDI-Public: 00814548015163
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• 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): 04/01/2021
• 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: 01/12/2025
• Device Model Number: 400SMTXSFT0101
• Device Catalogue Number: 400SMTXSFT0101
• Device Lot Number: F95553
• 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: 04/01/2021
• Initial Report FDA Received Date: 04/29/2021
• 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