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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2020
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 right ascending pharyngeal artery using penumbra smart coils (smart coil), a non-penumbra coils, non-penumbra microcatheter and a non-penumbra guide catheter.During the procedure, the physician successfully implanted two non-penumbra coils, and one smart coil in the target vessel using the microcatheter.While attempting to advance an additional smart coil into the microcatheter, the physician experienced resistance, and the smart coil would not advance within its introducer sheath.Therefore, the smart coil was removed.The procedure was completed using the same microcatheter, two additional smart coils and two 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 pusher assembly.The pusher assembly was kinked approximately 135.0 cm and 136.0 cm from the proximal end.The embolization coil was intact with the pusher assembly and had offset coil winds.The introducer sheath was kinked approximately 10.0 cm from its distal tip.Conclusions: evaluation of the returned smart coil revealed a kink on the introducer sheath.If the introducer sheath is forcefully mishandled during use, damage such as a kink may occur.If the smart coil is advanced through the kinked introducer sheath, resistance may be encountered, and the smart coil may not be advanced out of the introducer sheath.Forceful advancement the device against this resistance may result in the offset coil winds on the embolization coil and kinks on the pusher assembly.During functional testing, the smart coil was able to advance through the introducer sheath with resistance due to the kink on the introducer sheath.The smart coil was unable to be advanced through a demonstration microcatheter due to the offset coil winds on the embolization coil.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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10650002
• Report Number: 3005168196-2020-01659
• Device Sequence Number: 3871291
• 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
• Report Date (Section B): 09/13/2020
• 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: 03/05/2024
• Device Model Number: 400SMTHXSFT1H04
• Device Catalogue Number: 400SMTHXSFT1H04
• Device Lot Number: F88921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/13/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Date Report Sent to FDA: 01/01/2005