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

Catalog Number	400SMTXSFT0408
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	01/09/2019
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 internal carotid-posterior communicating artery (ic-pc) using penumbra smart coils (smart coils).During the procedure, the physician successfully placed two coils into the target vessel using a non-penumbra microcatheter.While advancing the third coil, a smart coil, through its introducer sheath, the physician felt resistance and the smart coil was unable to advance out of its introducer sheath into the microcatheter.The smart coil was therefore removed and was not used in the procedure.The procedure was completed using additional coils and a smart coil, as well as the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact at the proximal end of the pusher assembly.Bends and kinks were present approximately 9.0 cm, 23.0 cm, 49.0 cm, 65.0 cm, 89.0 cm, 103.0 cm and 118.0 cm from the proximal end.The pusher assembly mid-joint was proximal to the introducer sheath.The embolization coil had offset coil winds on its proximal end and was intact with the pusher assembly distal detachment tip (ddt).Contrast was found within the distal tip of the introducer sheath.Conclusions: evaluation of the returned smart coil revealed contrast within the distal tip of the introducer sheath.If there is contrast within the introducer sheath, it may prevent the smart coil from advancing out.Further evaluation revealed offset coil winds along the embolization coil.This damage was likely a result of advancing the coil against resistance.The contrast may have contributed to the inability to advance the coil through the introducer sheath during the procedure which then may have caused the offset coil winds.During functional testing, the contrast was cleared and the smart coil was able to advance through the introducer sheath with minor resistance.However, the smart coil was unable to advance through the hub of a demonstration microcatheter.The offset coil winds likely contributed to the resistance experienced during functional testing.Bends and kinks were also present along the length of the pusher assembly.These damages 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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8344366
• Report Number: 3005168196-2019-00268
• Device Sequence Number: 11241587
• Product Code: HCG
• UDI-Device Identifier: 00814548015392
• UDI-Public: 00814548015392
• 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): 01/16/2019
• 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: 03/12/2022
• Device Catalogue Number: 400SMTXSFT0408
• Device Lot Number: F74918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 05/03/2019
• 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
• Patient Weight: 45
• Date Report Sent to FDA: 01/01/2005