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

Model Number	400SMTSFT0820
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2020
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.This report is associated with mfr report number: 1.3005168196-2020-00493.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior cerebral artery (aca) using penumbra smart coils (smart coils), non-penumbra microcatheter and, non-penumbra guide catheter.During the procedure, the physician advanced the microcatheter from the aca to the right internal carotid artery (ica) with the guide catheter and placed four coils in the target vessel.While advancing a smart coil through the microcatheter, the physician experienced resistance in the middle of the microcatheter and, therefore, the smart coil was removed.Next, the physician placed a new smart coil and another coil in the vessel.The physician then attempted to advance another smart coil; however, the same issue occurred, and therefore, the smart coil was removed.The procedure was completed using new smart coils, other coils 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assembly.The pusher assembly was kinked approximately 138.0 cm from the proximal end.The pusher assembly mid-joint was retracted through the introducer sheath friction lock.The introducer sheath friction lock was wrinkled.The embolization coil was undamaged and intact with the pusher assembly.Conclusions: evaluation of the first returned smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.During functional testing, the smart coil was advanced through its introducer sheath with resistance while advancing the pusher assembly mid-joint through the introducer sheath friction lock.Subsequently, the smart coil was advanced through a demonstration microcatheter without an issue.Further evaluation revealed pusher assembly kinks on the proximal shaft and near the mid-joint.The kink near the mid-joint was likely a result of mishandling during advancement against resistance.The proximal kinks were likely incidental to the reported complaint.Evaluation of the second returned smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.During functional testing, the smart coil was advanced through its introducer sheath with resistance while advancing the pusher assembly mid-joint through the introducer sheath friction lock.Subsequently, the smart coil was advanced through a demonstration microcatheter without an issue.Further evaluation revealed a kink near the mid-joint.This kink was likely a result of mishandling during advancement against resistance.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.This report is associated with mfr report number: 1.3005168196-2020-00493.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9917969
• Report Number: 3005168196-2020-00494
• Device Sequence Number: 2732749
• Product Code: HCG
• UDI-Device Identifier: 00814548014753
• UDI-Public: 00814548014753
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020
• 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: 01/27/2024
• Device Model Number: 400SMTSFT0820
• Device Catalogue Number: 400SMTSFT0820
• Device Lot Number: F88177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 06/25/2020
• 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