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

Model Number	400SMTXSFT2H08
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the pusher assembly kink observed near the mid-joint.During functional testing, strong resistance was experienced while attempting to advance the smart coil from its returned position within the introducer sheath, and the smart coil could not be advanced at all.Further evaluation revealed an additional pusher assembly kink.This damage was likely incidental to the reported complaint.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.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 embolization procedure using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, a smart coil would not unsheath when entering the hub of the microcatheter.Therefore, the smart coil was removed.The procedure was completed using a non-penumbra coil 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: 11649497
• Report Number: 3005168196-2021-00724
• Device Sequence Number: 17058249
• Product Code: HCG
• UDI-Device Identifier: 00814548015576
• UDI-Public: 00814548015576
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 03/14/2021
• 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: 09/24/2025
• Device Model Number: 400SMTXSFT2H08
• Device Catalogue Number: 400SMTXSFT2H08
• Device Lot Number: F100564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• 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: 03/14/2021
• Initial Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 91
• Date Report Sent to FDA: 01/01/2005