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

Catalog Number	400SMTSTD0830
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2019
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 artery (ica) using penumbra smart coils (smart coil).During the procedure, the physician successfully placed smart coils in the target vessel.While attempting to place a new smart coil as the ninth coil in the target vessel, the physician was unable to advance a smart coil from its initial position within the introducer sheath, despite flushing the coil.Therefore, the smart coil was removed.The procedure was completed using new smart coils with 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pusher assembly.The embolization coil was undamaged and intact with its pusher assembly.The pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.A ring gauge (fx 7487) was advanced over the pusher assembly mid-joint to measure the outer diameter (od) and found to be within specification.A pin gauge was inserted into proximal end of the introducer sheath to measure the inner diameter (id) of the friction lock and found it to be within specification.Conclusions: evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If the pusher assembly mid-joint is retracted proximal to the introducer sheath friction lock, resistance may be experienced when attempting to advance the device.The od of the pusher assembly¿s mid-joint and the id of the introducer sheath friction lock were measured and found to be within specification.During functional testing, the returned smart coil was properly re-sheathed by the penumbra investigator.Then the returned smart coil was able to be advanced through a demonstration microcatheter and out of the distal tip without an issue.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: 8402103
• Report Number: 3005168196-2019-00426
• Device Sequence Number: 16240539
• Product Code: HCG
• UDI-Device Identifier: 00814548014524
• UDI-Public: 00814548014524
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2019
• 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: 10/15/2022
• Device Catalogue Number: 400SMTSTD0830
• Device Lot Number: F80019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005