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

Model Number	400SMTXSFT0308
Medical Device Problem Codes	Failure to Advance (2524); 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	12/21/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the cavernous sinus using penumbra smart coils (smart coil), non-penumbra coils, non-penumbra microcatheters, and balloon catheter.During the procedure, the physician placed three smart coils and four other coils using the microcatheter.Subsequently, the physician attempted to advance another smart coil into the microcatheter; however, the smart coil was stuck within its introducer sheath and would not advance at all.Therefore, it was removed.The procedure was completed a new smart coil, other coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted within the introducer sheath friction lock.If this occurs, resistance will likely be experienced while advancing the device and the device may not be advanced out of the introducer sheath.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance.After the pusher assembly mid-joint passed through the introducer sheath friction lock, the smart coil was able to advance through its introducer sheath without an issue.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.H3 other text : placeholder.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11206017
• Report Number: 3005168196-2021-00128
• Device Sequence Number: 3372444
• Product Code: HCG
• UDI-Device Identifier: 00814548015361
• UDI-Public: 00814548015361
• 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): 12/23/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2025
• Device Model Number: 400SMTXSFT0308
• Device Catalogue Number: 400SMTXSFT0308
• Device Lot Number: F100761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 02/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 49
• Date Report Sent to FDA: 01/01/2005