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

Model Number	400SMTHXSFT1H04
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/22/2019
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 meningeal artery (mma) using penumbra smart coils (smart coils).During the procedure, the physician placed a smart coil and two other coils in the target vessel using a non-penumbra microcatheter.While attempting to advance a new smart coil, the physician experienced strong resistance and the smart coil would not advance within its introducer sheath; therefore, it was removed.The procedure was completed using new smart coils and other coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra smart coil (smart coil) pusher assembly.Kinks were present along the pusher assembly approximately 27.0, 66.5, 82.0, 86.5, 134.0 and 136.0 cm from the proximal end.The pusher assembly mid-joint was proximal to the introducer sheath friction lock.The friction lock was wrinkled.The embolization coil was intact with the pusher assembly distal detachment tip (ddt).Offset coil winds were present on the proximal end of the embolization coil.The introducer sheath was slightly ovalized approximately 5.0 cm from the distal end.Conclusions: evaluation of the returned smart coil revealed offset coil winds on the proximal end of the embolization coil, kinks on the pusher assembly, and a slight ovalization on the distal end of the introducer sheath.If the rotating hemostasis valve (rhv) is over-tightened on the introducer sheath, damage such as an ovalization on the introducer sheath may occur.If the introducer sheath is ovalized, resistance may be experienced while advancing the smart coil within its introducer sheath.If the device is forcefully advanced against resistance, damage such as offset coil winds and pusher assembly kinks may occur.The offset coil winds likely contributed to the resistance experienced while advancing the smart coil within the introducer sheath during functional testing.Further evaluation revealed additional pusher assembly kinks.These kinks were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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.H3 other text : placeholder.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report: 3005168196-2019-01129.1.Section h.Box 4.Device manufacture date 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: 8683298
• Report Number: 3005168196-2019-01129
• Device Sequence Number: 2260057
• Product Code: HCG
• UDI-Device Identifier: 00814548015675
• UDI-Public: 00814548015675
• 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,Followup
• Report Date (Section B): 05/13/2019
• 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: 03/08/2023
• Device Model Number: 400SMTHXSFT1H04
• Device Catalogue Number: 400SMTHXSFT1H04
• Device Lot Number: F82244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 07/22/2019; 01/14/2005
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 07/29/2019; 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Date Report Sent to FDA: 01/01/2005