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

Catalog Number	400SMTXSFT0206
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2019
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 to treat a carotid cavernous fistula using penumbra smart coils (smart coils).During the procedure, a smart coil was stuck at the starting position and would not advance within its introducer sheath; therefore, it was removed.The procedure was completed using other smart coils and penumbra coil 400s (pc400s).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 was kinked approximately 29.5, 81.0, 130.0 and 149.0 cm from the proximal end of the pusher assembly.The smart coil was returned advanced out of the introducer sheath.The embolization coil was intact with the pusher assembly distal detachment tip (ddt).Offset coil winds were present on the proximal end of the embolization coil.The introducer sheath was ovalized approximately 4.0 cm from the distal end.Conclusions: evaluation of the returned smart coil revealed offset coil winds on the proximal end of the embolization coil.If the smart coil is advanced against resistance, damage such as offset coil winds may occur.During functional testing, the smart coil was re-sheathed.The smart coil was then able to be advanced out of the introducer sheath with resistance.Resistance was also experienced while attempting to advance the smart coil through the hub of a demonstration microcatheter and the smart coil could not advance any further.Further evaluation revealed pusher assembly kinks and an ovalization on the introducer sheath.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.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: 8866289
• Report Number: 3005168196-2019-01532
• Device Sequence Number: 14141998
• Product Code: HCG
• UDI-Device Identifier: 00814548016030
• UDI-Public: 00814548016030
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• 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): 07/09/2019
• 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: 09/05/2023
• Device Catalogue Number: 400SMTXSFT0206
• Device Lot Number: F85696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 08/28/2019
• 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