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

Catalog Number	400SMTSFT4H10
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	11/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 35.0 and 125.0 cm from the proximal end.The embolization coil was undamaged and intact with its pusher assembly.Conclusions: evaluation of the returned smart coil revealed that the device was functional.During the functional test, the smart coil was advanced through a demonstration microcatheter and out of the distal tip without an issue.The non-penumbra microcatheter identified in complaint was not returned for evaluation.Therefore, the root cause of the resistance experienced during the procedure could not be determined.Further evaluation of the returned smart coil revealed that the pusher assembly was kinked.These kinks were likely incidental to the reported failure and may have occurred during packaging for return to penumbra.Evaluation of the returned handle revealed that the device was functional.The handle was functionally tested and performed within specification.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are visually inspected and 100% functionally tested during incoming inspection after manufacturing.This report is associated with mfr report number: 3005168196-2018-02470.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, the physician attempted to advance the first smart coil into the target vessel using a non-penumbra microcatheter, and felt strong resistance.The smart coil only advanced approximately 9cm into the microcatheter and became stuck inside.Therefore, the smart coil was removed.The physician then advanced a second smart coil into the target vessel but could not detach it using the handle and it retreated 2cm into the microcatheter.A second attempt was then made to detach the smart coil and the same issue occurred and the smart coil retreated 1cm into the microcatheter.The physician then manually detached the coil, however, part of the smart coil remained in the microcatheter.Subsequently, the pusher assembly of the smart coil was used to advance the smart coil into the target vessel.The procedure was completed using additional coils and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8187658
• Report Number: 3005168196-2018-02464
• Device Sequence Number: 14151316
• Product Code: HCG
• UDI-Device Identifier: 00814548017051
• UDI-Public: 00814548017051
• 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
• Report Date (Section B): 11/20/2018
• 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: 03/05/2022
• Device Catalogue Number: 400SMTSFT4H10
• Device Lot Number: F74800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/20/2018
• 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