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

Model Number	400SMTXSFT0410
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 middle cerebral artery (mca) using a penumbra smart coil (smart coil) and a non-penumbra microcatheter.During the procedure, while advancing a smart coil into the hub of the microcatheter, the physician experienced resistance.Therefore, the smart coil was removed.The procedure was completed using additional smart 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 introducer sheath was loaded backwards.If the introducer sheath is loaded incorrectly during use, resistance may be experienced during advancement and damage such as this may occur.Further evaluation revealed offset coil winds and kink in the pusher assembly.This damage was incidental to the reported complaint and may have occurred due to the advancement against resistance.During functional testing, the smart coil was properly re-sheathed, and advanced out of its introducer sheath without an issue.Resistance was encountered while attempting to advance the smart coil through a demonstration microcatheter due to the offset coil winds on the proximal end of the embolization coil, and the device could not be advanced any further.Penumbra coils are visually 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.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: 11820189
• Report Number: 3005168196-2021-01025
• Device Sequence Number: 3510367
• Product Code: HCG
• UDI-Device Identifier: 00814548015408
• UDI-Public: 00814548015408
• Combination Product (Y/N): Y
• Initial Reporter Country: GT
• 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): 04/19/2021
• 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: 10/01/2023
• Device Model Number: 400SMTXSFT0410
• Device Catalogue Number: 400SMTXSFT0410
• Device Lot Number: F86162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005