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

Model Number	400SMTHXSFT0202
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2020
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 in the anterior communicating artery (acom) using penumbra smart coils (smart coils), non-penumbra coils, and a non-penumbra microcatheter (sl-10).It was noted that the patient anatomy was slightly tortuous, narrowed, and mildly calcified.During the procedure, the physician successfully placed two smart coils and seven non-penumbra coils in the target location using the sl-10.Then, the physician was unable to advance another smart coil beyond the distal end of the introducer sheath; therefore, it was removed.The procedure was completed using another smart coil and the same sl-10.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization in the anterior communicating artery (acom) using penumbra smart coils (smart coils), non-penumbra coils, and a non-penumbra microcatheter.It was noted that the patient anatomy was slightly tortuous, narrowed, and mildly calcified.During the procedure, the physician successfully placed two smart coils and seven non-penumbra coils in the target location using the microcatheter.Then, the physician was unable to advance another smart coil beyond the distal end of the introducer sheath; therefore, it was removed.The procedure was completed using another smart coil and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2020-00137.1.Section b.Box 5.Describe event or problem results: slight bends were present along the pusher assembly.The pet lock was intact on the proximal end of the pusher assembly.The pusher assembly mid-joint was retracted through the introducer sheath friction lock.The embolization coil was undamaged and intact with the pusher assembly.Conclusions: evaluation of the returned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 bends along the pusher assembly.These bends were likely incidental to the reported complaint.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: 9682382
• Report Number: 3005168196-2020-00137
• Device Sequence Number: 3654751
• Product Code: HCG
• UDI-Device Identifier: 00814548015699
• UDI-Public: 00814548015699
• 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): 01/10/2020
• 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: 06/13/2022
• Device Model Number: 400SMTHXSFT0202
• Device Catalogue Number: 400SMTHXSFT0202
• Device Lot Number: F77672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 03/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 69
• Date Report Sent to FDA: 01/01/2005