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

Model Number	400SMTSFT3H08
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2021
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the transverse sinus using penumbra smart coils (smart coil), non-penumbra coils, and a non-penumbra microcatheter.It was noted that the patient¿s anatomy was mildly tortuous and calcified.During the procedure, the physician placed a smart coil and three other coils in the target vessel using the microcatheter.While advancing another smart coil through the microcatheter, the physician then experienced resistance in the middle of the microcatheter.Subsequently, the physician replaced the microcatheter with another microcatheter and attempted to advance the same smart coil through the microcatheter.However, the physician experienced resistance again in the middle of the microcatheter; therefore, the smart coil was removed.The procedure was completed using a new smart coil, additional smart coils, other coils, and the same microcatheter.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: 11948580
• Report Number: 3005168196-2021-01264
• Device Sequence Number: 16409254
• Product Code: HCG
• UDI-Device Identifier: 00814548017013
• UDI-Public: 00814548017013
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2021
• 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: 11/29/2021
• Device Model Number: 400SMTSFT3H08
• Device Catalogue Number: 400SMTSFT3H08
• Device Lot Number: F72919
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005