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

Model Number	400SMTXSFT0306
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2019
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 cerebral aneurysm using penumbra smart coils (smart coil), non-penumbra coils, non-penumbra guide catheter and non-penumbra microcatheter.It was reported that the patient¿s anatomy was tortuous, and the vessel had calcified plaques.During the procedure, the physician placed three smart coils and fourteen non-penumbra coils using the microcatheter in the aneurysm.The physician encountered resistance while attempting to advance the fourth smart coil twice beyond the hub of the microcatheter.Therefore, the smart coil was removed.The procedure was completed using a smart coil, two non-penumbra 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assembly.The pusher assembly was kinked at approximately 139.0 cm from the proximal end.The pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The embolization coil was undamaged and intact with the pusher assembly.Conclusions: evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If the pusher assembly mid-joint become retracted through the introducer sheath friction lock, resistance will likely be experienced while advancing the device.Forcefully advancing the device against this resistance may have contributed to the pusher assembly kink near its mis-joint.During functional testing, the embolization coil was unable to advance within its introducer sheath due to the mid-joint was retracted proximal to the friction lock.After proper re-sheathed the device into its introducer sheath, the embolization coil was able to be advanced through its introducer sheath and a demonstration microcatheter without issue.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.H3 other text : placeholder.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9477434
• Report Number: 3005168196-2019-02327
• Device Sequence Number: 11428035
• Product Code: HCG
• UDI-Device Identifier: 00814548015354
• UDI-Public: 00814548015354
• 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): 11/18/2019
• 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: 08/29/2022
• Device Model Number: 400SMTXSFT0306
• Device Catalogue Number: 400SMTXSFT0306
• Device Lot Number: F78957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 02/16/2020
• 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