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

Catalog Number	400SMTHXSFT0408
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2019
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 left posterior cerebral artery (pca) using penumbra smart coils (smart coil).During the procedure, after advancing the smart coil approximately 10 centimeters past the hub of a non-penumbra microcatheter, the smart coil and pusher assembly became stuck and the smart coil was unable to advance any further; therefore, it was removed.The physician then attempted to advance the same smart coil; however, the same issue occurred and therefore, it was removed.The procedure was then completed using a new smart coil with 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 18.0 and 73.0 cm from the proximal end.The embolization coil was intact with its pusher assembly and had offset coil winds.Conclusions: evaluation of the returned smart coil revealed that the embolization coil winds were offset.If the introducer sheath is not properly aligned within the hub of the microcatheter, resistance maybe experienced.If the smart coil is forcefully advanced against resistance, damage such as offset coil winds may occur.The offset coil winds likely contributed to the reported inability to advance the device.During functional testing, resistance was encountered while attempting to advance the returned smart coil through a demonstration microcatheter and the coil was stuck inside the hub of the microcatheter.Further evaluation revealed kinks on the pusher assembly that were likely incidental to the reported complaint.The non-penumbra microcatheter was not returned to penumbra for evaluation.Penumbra coils are visually inspected during in-process inspection 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: 8568748
• Report Number: 3005168196-2019-00843
• Device Sequence Number: 1638910
• Product Code: HCG
• UDI-Device Identifier: 00814548015828
• UDI-Public: 00814548015828
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 04/02/2019
• 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: 04/09/2022
• Device Catalogue Number: 400SMTHXSFT0408
• Device Lot Number: F75524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 70
• Date Report Sent to FDA: 01/01/2005