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

Model Number	400SMTHXSFT0308
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2020
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 left internal carotid artery (ica) using a penumbra smart coil (smart coil).During the procedure, the smart coil would not advance within its introducer sheath; therefore, it was removed.The procedure was completed using a new smart coil.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 kinks and bends throughout its length.The embolization coil was intact with its pusher assembly and had offset coil winds.The introducer sheath was loaded backwards on the pusher assembly.Conclusions: evaluation of the returned smart coil revealed that the introducer sheath was loaded backward on the pusher assembly and the embolization coil had offset coil winds.The introducer sheath friction lock has a smaller inner diameter (id) than the pusher assembly mid-joint, which allows the introducer sheath to seat properly on the pusher assembly.If the introducer sheath is loaded backwards during handling prior to use, resistance may be encountered during advancement and damage such as offset coil winds may occur.During the functional test, after properly re-sheathing the smart coil, resistance was encountered while attempting to advance the smart coil through the hub of a demonstration microcatheter as the offset coil winds bunched up inside the hub of the microcatheter and the smart coil could not be advanced any further.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: 10255461
• Report Number: 3005168196-2020-00907
• Device Sequence Number: 11476448
• Product Code: HCG
• UDI-Device Identifier: 00814548015798
• UDI-Public: 00814548015798
• Combination Product (Y/N): Y
• Initial Reporter Country: EC
• 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): 06/19/2020
• 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: 04/02/2024
• Device Model Number: 400SMTHXSFT0308
• Device Catalogue Number: 400SMTHXSFT0308
• Device Lot Number: F89378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Date Report Sent to FDA: 01/01/2005