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

Catalog Number	400SMTXSFT0104
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2019
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra smart coils (smart coils).During the procedure, a 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 embolization coil was intact with the pusher assembly and had offset coil winds.The pusher assembly outer diameter was measured and was within specification.Conclusions: evaluation of the returned smart coil revealed offset coil winds on the proximal end of the embolization coil.If the introducer sheath is not properly aligned inside the hub of the parent device prior to advancement, resistance may be encountered.If the device is forcefully advanced against this resistance, damage such as offset coil winds may occur.During functional testing, the embolization coil was advanced out of its introducer sheath without an issue but was unable to advance into the hub of a demonstration microcatheter due to the offset coil winds.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: 8965742
• Report Number: 3005168196-2019-01706
• Device Sequence Number: 2088666
• Product Code: HCG
• UDI-Device Identifier: 00814548015507
• UDI-Public: 00814548015507
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2019
• 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: 10/18/2021
• Device Catalogue Number: 400SMTXSFT0104
• Device Lot Number: F72373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Date Report Sent to FDA: 01/01/2005