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

Model Number	400SMTSFT0515
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	10/23/2020
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 middle meningeal artery (mma) using penumbra smart coils (smart coils) and a non-penumbra microcatheter.It was noted that the patient's anatomy was tortuous and calcified.During the procedure, the physician implanted two smart coils into the target location.While attempting to advance the next smart coil into the hub of the microcatheter, the physician encountered resistance and reported that the smart coil would not exit its introducer sheath.Therefore, the smart coil was removed.The procedure was completed using six smart coils, three non-penumbra coils, and the same microcatheter.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 101.0 cm and 103.0 cm from the proximal end.The embolization coil was intact with the pusher assembly and had offset coil winds.Conclusions: evaluation of the returned smart coil revealed offset coil winds on the embolization coil and kinks on the pusher assembly.If the smart coil is advanced through inside the tortuous patient¿s anatomy, resistance may be encountered and damage such as this may occur.During functional testing, the smart coil was able to be advanced through its introducer sheath and a demonstration microcatheter with resistance due to the kinks on the pusher assembly.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: 10870517
• Report Number: 3005168196-2020-02039
• Device Sequence Number: 16944879
• Product Code: HCG
• UDI-Device Identifier: 00814548014944
• UDI-Public: 00814548014944
• 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): 10/26/2020
• 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: 03/03/2025
• Device Model Number: 400SMTSFT0515
• Device Catalogue Number: 400SMTSFT0515
• Device Lot Number: F96689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Date Report Sent to FDA: 01/01/2005