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

Model Number	400SMTSTD0615
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2020
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 using a penumbra smart coil (smart coil) and a microcatheter.During the procedure, while advancing the smart coil through the microcatheter, the smart coil kinked; therefore, it was removed.The procedure was completed using penumbra coils.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 fractured approximately 137.0 cm from the proximal end and was kinked approximately 138.5 cm from the proximal end.The pusher assembly mid-joint was retracted into the introducer sheath friction lock.The embolization coil was detached from the pusher assembly within the introducer sheath.Conclusions: evaluation of the returned smart coil revealed that the pusher assembly was kinked and fractured near the mid-joint, and the embolization coil was detached from the pusher assembly.Further evaluation revealed that the pusher assembly mid-joint was retracted into the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement, and damage such as a kink subsequent fracture may occur.If the two fractured pusher assembly segments are separated, the pull wire may retract out of the distal detachment tip and detach the embolization coil 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: 10459744
• Report Number: 3005168196-2020-01294
• Device Sequence Number: 2147251
• Product Code: HCG
• UDI-Device Identifier: 00814548014661
• UDI-Public: 00814548014661
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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): 08/08/2020
• 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: 12/02/2023
• Device Model Number: 400SMTSTD0615
• Device Catalogue Number: 400SMTSTD0615
• Device Lot Number: F87325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/08/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Date Report Sent to FDA: 01/01/2005