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

Catalog Number	400SMTSTD1445
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2019
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 posterior communicating artery (pcom) using penumbra 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 pusher assembly was kinked approximately 17.5, 101.0, 136.0 and 139.0 cm from the proximal end.The pusher assembly was fractured approximately 137.0 cm from the proximal end.The pusher assembly mid-joint was positioned proximal to the introducer sheath friction lock.The embolization coil was undamaged and detached from the pusher assembly distal detachment tip (ddt).Conclusions: evaluation of the returned smart coil revealed the pusher assembly mid-joint was positioned proximal to the introducer sheath friction lock, pusher assembly kinks and a fracture.If the pusher assembly is retracted proximal to the introducer sheath friction lock, resistance may be experienced during advancement.Subsequently, if the device is forcefully mishandled while advancing against resistance, damage such as a kinked pusher assembly may occur.If a kinked device is further manipulated, the kink may worsen to a fracture.Further evaluation revealed a detached embolization coil.If the pusher assembly fractured segments are separated, the pull wire may retract out of the pusher assembly ddt causing the embolization coil to detach from its pusher assembly.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: 8786045
• Report Number: 3005168196-2019-01356
• Device Sequence Number: 2338643
• Product Code: HCG
• UDI-Device Identifier: 00814548014272
• UDI-Public: 00814548014272
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 06/13/2019
• 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: 09/19/2022
• Device Catalogue Number: 400SMTSTD1445
• Device Lot Number: F79594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Date Report Sent to FDA: 01/01/2005