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

Model Number	400SMTHXSFT1H03
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
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.This report is associated with mfr report number: 3005168196-2020-00791.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the superficial temporal artery (sta) using penumbra smart coils (smart coils), non-penumbra coils, and a non-penumbra microcatheter.It was reported that the patient¿s anatomy was tortuous, narrowed and calcified.During the procedure, the physician placed two coils in the target vessel using the microcatheter.While advancing the next coil, a smart coil, out of the introducer sheath, the physician experienced resistance, and the smart coil became stuck at the distal end; therefore, it was removed.The physician then continued the procedure and placed a smart coil and three other coils.While advancing the third smart coil out of the introducer sheath, the smart coil became stuck at the same position as the first smart coil; therefore, it was also removed.The procedure was completed using a non-penumbra coil, the same microcatheter, and n-butyl cyanoacrylate (nbca) injection.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 had bends along its length.The pusher assembly was kinked approximately 137.0 cm from the proximal end.The pusher assembly mid-joint was proximal to the introducer sheath friction lock.The embolization coil was undamaged and intact with the pusher assembly.Conclusions: evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Further evaluation revealed a pusher assembly kink near the mid-joint.This damage may have occurred during advancement against resistance.During functional testing, the smart coil was advanced through its introducer sheath with resistance while advancing the pusher assembly mid-joint through the introducer sheath friction lock.The smart coil was then advanced through a demonstration microcatheter with resistance due to the pusher assembly kink.Further evaluation revealed additional pusher assembly bends and kinks.These damages were 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.This report is associated with mfr report number: 3005168196-2020-00791 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: 10172581
• Report Number: 3005168196-2020-00790
• Device Sequence Number: 16875063
• Product Code: HCG
• UDI-Device Identifier: 00814548015668
• UDI-Public: 00814548015668
• 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): 05/24/2020
• 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: 08/23/2022
• Device Model Number: 400SMTHXSFT1H03
• Device Catalogue Number: 400SMTHXSFT1H03
• Device Lot Number: F78837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/24/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005