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

Catalog Number	400SMTXSFT1H02
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2018
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 anterior communicating artery using penumbra smart coils (smart coils).During the procedure, the physician successfully deployed and detached multiple smart coils using a non-penumbra microcatheter.The physician then experienced resistance and was unable to advance a smart coil through the hub of the microcatheter, and therefore the smart coil was removed.The procedure was then completed using a new smart coil and the same microcatheter.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 28.0, 76.0, and 138.0 cm from the proximal end.The embolization coil was intact with its pusher assembly.Conclusions: evaluation of the returned smart coil revealed that the device was able to be advanced through a demonstration microcatheter.During the functional test, resistance was encountered as the kinks in the pusher assembly was advanced through the demonstration microcatheter.However, the smart coil able to be advanced completely through the microcatheter and out of the distal tip.The root cause of the smart coil not be able to be advanced through the hub of the microcatheter during the procedure could not be determined.Further evaluation of the smart coil revealed that the pusher assembly was kinked.These kinks were likely incidental to the reported issue and may have occurred while packaging the device for return to penumbra.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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7408928
• Report Number: 3005168196-2018-00723
• Device Sequence Number: 1252097
• Product Code: HCG
• UDI-Device Identifier: 00814548015224
• UDI-Public: 00814548015224
• 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): 03/13/2018
• 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: Physician
• Device Expiration Date: 02/01/2022
• Device Catalogue Number: 400SMTXSFT1H02
• Device Lot Number: F74140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 04/09/2018
• Supplement Report FDA Received Date: 08/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Date Report Sent to FDA: 01/01/2005