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

Catalog Number	400SMTSFT0410
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2019
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 superior mesenteric artery (sma) using penumbra smart coils (smart coil).During the procedure, the physician successfully placed two smart coils in the target vessel using a non-penumbra microcatheter.The physician then advanced a new smart coil halfway into the microcatheter; however, the introducer sheath was sticking firmly to the pusher assembly.Therefore, the smart coil was removed.The procedure was completed using new smart coils and other coils 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 at approximately 7.0 cm, 9.0 cm and 28.0 cm from the proximal end.The returned smart coil pusher assembly mid-joint and embolization coil was advanced out distal to the introducer sheath.The introducer sheath was moved to the proximal side of the pusher assembly.The embolization coil was intact with the pusher assembly and had offset coil winds.The pusher assembly was able to advance through the 0.0159¿ ring gauge and the mid-joint outer diameter (od) was within specification.Conclusions: evaluation of the returned smart coil revealed a fully functional device.During the functional testing, the smart coil was able to advance through its introducer sheath and demonstration microcatheter without an issue.The reported complaint was unable to be confirmed.Further investigation revealed that the pusher assembly had kinks near its proximal end and embolization coil had offset coil winds.These damages 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: 8413313
• Report Number: 3005168196-2019-00456
• Device Sequence Number: 2205747
• Product Code: HCG
• UDI-Device Identifier: 00814548015095
• UDI-Public: 00814548015095
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2019
• 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: 02/25/2023
• Device Catalogue Number: 400SMTSFT0410
• Device Lot Number: F82073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 04/18/2019
• 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