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

Catalog Number	400SMTXSFT0408
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	01/17/2019
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 using penumbra smart coils (smart coils).During the procedure, the physician successfully placed three coils using a non-penumbra microcatheter.The physician then felt resistance and was unable to advance a smart coil through the hub of the microcatheter.Therefore, the smart coil was removed, and the procedure was successfully completed using new smart 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Results: the pet lock was intact on the proximal end of the pusher assembly.The smart coil pusher assembly mid-joint was retracted into the introducer sheath friction lock.The embolization coil was intact with the pusher assembly and was undamaged.The pusher assembly was able to advance through the 0.0159¿ ring gauge and the mid-joint od was within specification.Conclusions: evaluation of the returned smart coil revealed the pusher assembly mid-joint was retracted into the introducer sheath friction lock.If the mid-joint become retracted into the friction lock, resistance will likely be experienced while advancing the device.During the functional testing, smart coil was properly re-sheathed into its introducer sheath and was able to be advanced through the introducer sheath and the demonstration delivery microcatheter without an issue.The mid-joint od was measured with the 0.0159¿ ring gauge and it was within the specification.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.
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 3005168196-2019-00357 mfr report: 1.Section h.Box10.Narrative/corrected data.Results: the pet lock was intact on the proximal end of the pusher assembly.The smart coil pusher assembly mid-joint was retracted into the introducer sheath friction lock.The embolization coil was intact with the pusher assembly and was undamaged.The mid-joint od was within specification.Conclusions: evaluation of the returned smart coil revealed the pusher assembly mid-joint was retracted into the introducer sheath friction lock.If the mid-joint become retracted into the friction lock, resistance will likely be experienced while advancing the device.After unseating the pusher assembly mid-joint from the friction lock, the smart coil was advanced through a demonstration microcatheter without issue.The reported complaint could not be confirmed.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: 8370433
• Report Number: 3005168196-2019-00357
• Device Sequence Number: 13717745
• Product Code: HCG
• UDI-Device Identifier: 00814548015392
• UDI-Public: 00814548015392
• 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,Followup
• Report Date (Section B): 01/28/2019
• 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: 12/07/2022
• Device Catalogue Number: 400SMTXSFT0408
• Device Lot Number: F80932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 04/08/2019; 01/14/2005
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 05/08/2019; 07/30/2019
• 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